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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “peripheral extent of each of the first and second compression elements being curved” and “concave edge”.
Drawings
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 peripheral extent of each of the first and second compression elements being curved 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 Objections
Claim 1 objected to because of the following informalities: “a compression surface apex dimensioned to extend across an anal orifice of the patient” should be “a compression surface apex configured to extend across an anal orifice of the patient” in lines 2-3. Appropriate correction is required.
Claim 1 objected to because of the following informalities: “a first surface facing the first buttock of the patient” should be “a first surface configured to face the first buttock of the patient” in line 5. Appropriate correction is required.
Claim 1 objected to because of the following informalities: “a second surface facing the second buttock of the patient” should be “a second surface configured to face the second buttock of the patient” in lines 9-10. Appropriate correction is required.
Claim 3 objected to because of the following informalities: “to skin of the first and second buttocks” should be “to the skin of the first and second buttocks” in line 3. Appropriate correction is required.
Claim 16 objected to because of the following informalities: “is thinner the gauze material” should be “is thinner than the gauze material” in line 2. Appropriate correction is required.
Claim 17 objected to because of the following informalities: “a compression surface apex dimensioned to extend across an anal orifice of a patient” should be “a compression surface apex configured to extend across an anal orifice of a patient” in lines 2-3. Appropriate correction is required.
Claim 17 objected to because of the following informalities: “a first surface comprising a first attachment feature facing the first buttock of the patient” should be “a first surface comprising a first attachment feature configured to face the first buttock of the patient” in lines 7-8. Appropriate correction is required.
Claim 17 objected to because of the following informalities: “a second surface comprising a soft material facing away from the first buttock” should be “a second surface comprising a soft material configured to face away from the first buttock” in line 8. Appropriate correction is required.
Claim 17 objected to because of the following informalities: “a third surface comprising a second attachment feature facing the second buttock of the patient” should be “a third surface comprising a second attachment feature configured to face the second buttock of the patient” in lines 12-13. Appropriate correction is required.
Claim 17 objected to because of the following informalities: “a fourth surface comprising the soft material facing away from the second buttock” should be “a fourth surface comprising the soft material configured to face away from the second buttock” in lines 13-14. Appropriate correction is required.
Claim 18 objected to because of the following informalities: “material.differnt” should be “material different” in line 2. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 7, 11, and 15 are 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. Claim 16 is also rejected due to its dependency to claim 15.
Claim 7 recites the limitation "the first distal end of the first compression element" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the second distal end of the second compression element" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “a concave edge” in line 2. It is unclear whether it is the same concave edge from claim 10 or a different concave edge. Examiner examined this claim as best understood.
Claim 15 recites the limitation “a gauze material” in line 2. It is unclear whether it is the same gauze material from claim 14 or a different gauze material. Examiner examined this claim as best understood.
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 1-4, 6, 8-11 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Embodiment A of Blurton et al. (US 20070260163 A1).
Regarding claim 1, Embodiment A of 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 1, a compression surface apex) dimensioned 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) facing 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 2, 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) facing 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 2, 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 2, a first flex region) between a proximal end of said first compression element (E – see annotated figure 2, proximal end of the first compression element) and said central support element (410) (see annotated figure 2, 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 2, a second flex region) between a proximal end of said second compression element (G – see annotated figure 2, proximal end of the second compression element) and said central support element (410) (see annotated figure 2, the second flex region [F] is between the proximal end of the second compression element [G] and the central support element [410]).
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Annotated figure 1: apparatus of Embodiment A of Blurton et al.
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Annotated figure 2: apparatus of Embodiment A of Blurton et al. in use
Regarding claim 2, Embodiment A of Blurton et al. discloses the invention as discussed in claim 1. Embodiment A of Blurton et al. further discloses wherein: the first (532) and second surfaces (522) comprise a loop portion of a hook and loop fastener (figure 18/figure 19, the first [532] and second surfaces [522] comprise loop portion of the hook and loop fastener: paragraph 0049/0052), the first (534) and second anchor pads (524) comprise a hook portion of the hook and loop fastener (536/546 – figure 18, the surface includes the second half of the hook and loop fastener [hooks]: paragraph 0049/0052), and the first (532) and second surfaces (522) are configured to releasably attach to the first (534) and second anchor pads (524), respectively, using the hook and loop fastener (figure 18/figure 19, the first surface [532] releasably attaches to the first anchor pad [534] via hook and loop fastener and the second surface [522] releasably attaches to the second anchor pad [524] via hook and loop fastener: paragraph 0049/0052).
Regarding claim 3, Embodiment A of Blurton et al. discloses the invention as discussed in claim 1. Embodiment A of Blurton et al. further discloses wherein the first (534) and second anchor pads (524) comprise respective adhesive segments configured to adhere to at least a portion of the first (538 – figure 18, first surface of the first anchor pad that has an adhesive surface: paragraph 0049) and second anchor pads (528 – figure 18, first surface of the second anchor pad that has an adhesive surface: paragraph 0049) to skin of the first (14) and second buttocks (15), respectively (figure 18/figure 19/figure 20, the at least a portion of the first [538] and second anchor pads [528] have adhesive coatings that adhere to the patient’s first [14] and second buttocks [15]: paragraph 0049/0052).
Regarding claim 4, Embodiment A of Blurton et al. discloses the invention as discussed in claim 1. Embodiment A of Blurton et al. further discloses wherein the first (530) and second resilient, flexible members (520) comprise a thin plastic substrate (300 – figure 18, a support device made of polycarbonate material: paragraph 0049) (the first [530] and second resilient, flexible members [520] are joined to the thin plastic substrate [300]: paragraph 0049).
Regarding claim 6, Embodiment A of Blurton et al. discloses the invention as discussed in claim 4. Embodiment A of Blurton et al. further discloses wherein the thin plastic substrate (300) is configured in a generally V-shaped form (figure 16/figure 18, the thin plastic substrate [300] is V-shaped: paragraph 0057).
Regarding claim 8, Embodiment A of Blurton et al. discloses the invention as discussed in claim 1. Embodiment A of Blurton et al. further discloses wherein the first (530) and second compression elements (520) comprise a first width (K – see annotated figure 1, a first width of the first [530] and second compression elements [520]) adjacent to the central support element (410) (see annotated figure 1, the first width [K] is near the central support element [410]) and a second width (L – see annotated figure 1, a second width of the first [530] and second compression elements [520]) proximate to first (539 – see annotated figure 1, lateral end of the first compression element [530]: paragraph 0049) and second distal ends (529 – see annotated figure 1, lateral end of the second compression element [520]: paragraph 0049) of the respective first (530) and second compression elements (520) (see annotated figure 1, the second width [L] is proximate to the first [539] and second distal ends [529]), the first width (K) being less than the second width (L) (see annotated figure 1/figure 20, the first width [K] is less than the second width [L]), a peripheral extent (M – see annotated figure 1, peripheral extent) of each of the first (530) and second compression elements (520) being curved (see annotated figure 1, the peripheral extent [M] of the first [530] and second compression elements [520] are curved).
Regarding claim 9, Embodiment A of Blurton et al. discloses the invention as discussed in claim 8. Embodiment A of Blurton et al. further discloses wherein the compression surface apex (A) comprises a contact width (312 – figure 14, an external pressure surface: paragraph 0045) that extends along a midline axis (320 – figure 14, midline axis: paragraph 0045) that extends longitudinally between a posterior edge (314 – figure 14, first end: paragraph 0045) and an anterior edge (316 – figure 14, an opposing end: paragraph 0045) of said perianal support device (500), and wherein said contact width (312) is greater than said first width (K) of said first (530) and second compression elements (520) respectively (see annotated figure 1/figure 14/figure 20, the contact width [312] is greater than the first width [K] of the first [530] and second compression elements [520]).
Regarding claim 10, Embodiment A of Blurton et al. discloses the invention as discussed in claim 9. Embodiment A of Blurton et al. further discloses wherein the first width (K) of the first (530) and second compression elements (520) respectively comprises a concave edge (N – see annotated figure 3, a concave edge on the thin plastic substrate [300 – figure 18, a support device made of polycarbonate material: paragraph 0049]) on at least one of said posterior edge (314) or said anterior edge (316) (see annotated figure 1/annotated figure 3, the first width [K] of the first [530] and second compression elements [520] comprises a concave edge [N] on both the posterior edge [314] and anterior edge [316] since it is joined with the thin plastic substrate [300]).
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Annotated figure 3: thin plastic substrate of Embodiment A of Blurton et al.
Regarding claim 11, Embodiment A of Blurton et al. discloses the invention as discussed in claim 10. Embodiment A of Blurton et al. further discloses wherein the first width (K) of the first (530) and second compression elements (520) respectively comprises a concave edge (N – see annotated figure 3, a concave edge on the thin plastic substrate [300 – figure 18, a support device made of polycarbonate material: paragraph 0049]) on both said posterior edge (314) and said anterior edge (316) (see annotated figure 1/annotated figure 3, the first width [K] of the first [530] and second compression elements [520] comprises a concave edge [N] on both the posterior edge [314] and anterior edge [316] since it is joined with the thin plastic substrate [300]).
Regarding claim 14, Embodiment A of Blurton et al. discloses the invention as discussed in claim 1. Embodiment A of Blurton et al. further discloses wherein the compression surface apex (A) comprises a gauze material (the central support element [410] comprising the compression surface apex can be made of a gauze pad: paragraph 0047/0049).
Regarding claim 15, Embodiment A of Blurton et al. discloses the invention as discussed in claim 14. Embodiment A of Blurton et al. further discloses wherein each of said first flex region (D) and said second flex region (F) comprises a gauze material (the first flex region [D] and the second flex region [F] each comprise a portion of the central support element [410] that can be made of a gauze pad: paragraph 0047/0049).
Claims 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Embodiment B of Blurton et al. (US 20070260163 A1).
Regarding claim 17, Embodiment B of Blurton et al. discloses a perianal support device (20 – figure 1/figure 2/figure 4, support device: paragraph 0034) comprising: a central support element (AA – see annotated figure 4, central support element) comprising a compression surface apex (30 – figure 4, a pressure surface: paragraph 0034) dimensioned to extend across an anal orifice of a patient (38 – figure 4, anal orifice of a patient: paragraph 0035) in a sagittal plane of the patient (figure 4, the central support element [AA] comprising the compression surface apex [30] is dimensioned to span across the anal orifice [38] when the perianal support device [20] is advanced toward the anal orifice [within the sagittal plane]: paragraph 0035); a first compression element (80 – figure 4, a securing member: paragraph 0034-0035) extending from the central support element (AA) in a first lateral direction (the first compression element [80] extends from the central support element [AA] in a first lateral direction; the first compression element [80] attaches to the first flange [60 – figure 1/figure 4] adjacent end portion [64 – figure 1/figure 4] and extends laterally from the midline [48 – figure 1] of the perianal support device [20]: paragraph 0034), the first compression element (80) comprising a first resilient, flexible member (the first compression element [80] is an elongated, flexible strips of adhesive tape: paragraph 0034) configured to follow a first contour of a first buttock of the patient (14 – figure 4, first buttock of the patient: paragraph 0035) (figure 4, the first compression element [80] follows the contour of a first buttock of the patient [14]: paragraph 0035), the first compression element (80) further comprising a first surface (AB – see annotated figure 4, first surface of the first compression element) comprising a first attachment feature (the first surface [AB] is releasably attached to the patient since the first compression element [80] is an elongated, flexible strips of adhesive tape: paragraph 0034-0035) facing the first buttock of the patient (14) (see annotated figure 4, the first surface [AB] faces the first buttock of the patient [14]), and a second surface (AC – see annotated figure 4, second surface of the first compression element) comprising a soft material (the first compression element [80] is a flexible adhesive tape that follows a contour of the first buttock of the patient [14]; therefore, it comprises a soft material due to its flexibility: paragraph 0034-0035) facing away from the first buttock (14) (see annotated figure 4, the second surface [AC] faces away from the first buttock of the patient [14]), a second compression element (81 – figure 4, a securing member: paragraph 0034-0035) extending from the central support element (AA) in a second lateral direction opposite the first lateral direction (the second compression element [81] extends from the central support element [AA] in a second lateral direction opposite the first lateral direction; the second compression element [81] attaches to the second flange [66 – figure 1/figure 4] adjacent end portion [70 – figure 1/figure 4] and extends laterally from the midline [48 – figure 1] of the perianal support device [20]: paragraph 0034), the second compression element (81) comprising a second resilient, flexible member (the second compression element [81] is an elongated, flexible strips of adhesive tape: paragraph 0034) configured to follow a second contour of a second buttock of the patient (15 – figure 4, second buttock of the patient: paragraph 0035) (figure 4, the second compression element [81] follows the contour of a second buttock of the patient [15]: paragraph 0035), the second compression element (81) further comprising a third surface (AD – see annotated figure 4, a third surface of the second compression element) comprising a second attachment feature (the third surface [AD] is releasably attached to the patient since the second compression element [81] is an elongated, flexible strips of adhesive tape: paragraph 0034-0035) facing the second buttock of the patient (15) (see annotated figure 4, the third surface [AD] faces the second buttock of the patient [15]), and a fourth surface (AE – see annotated figure 4, a fourth surface of the second compression element) comprising the soft material (the second compression element [81] is a flexible adhesive tape that follows a contour of the second buttock of the patient [15]; therefore, it comprises a soft material due to its flexibility: paragraph 0034-0035) facing away from the second buttock (15) (see annotated figure 4, the fourth surface [AE] faces away from the second buttock of the patient [15]); a first flex region (60 – figure 1/figure 4, first flange: paragraph 0034) connected to said central support element (AA) (see annotated figure 4, the first flex region [60] is connected to the central support element [AA]) and to a proximal end of said first compression element (AF – see annotated figure 4, proximal end of the first compression element) (see annotated figure 4, the first flex region [60] is connected to the proximal end of the first compression element [AF]: paragraph 0034); and a second flex region (66 – figure 1/figure 4, second flange: paragraph 0034) connected to said central support element (AA) (see annotated figure 4, the second flex region [66] is connected to the central support element [AA]) and to a proximal end of said second compression element (AG – see annotated figure 4, proximal end of the second compression element) (see annotated figure 4, the second flex region [66] is connected to the proximal end of the second compression element [AG]: paragraph 0034).
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Annotated figure 4: Embodiment B of Blurton et al.
Regarding claim 18, Embodiment B of Blurton et al. discloses the invention as discussed in claim 17. Embodiment B of Blurton et al. further discloses wherein each of said first flex region (60) and said second flex region (66) comprises material different from each of said first (80) and second compression elements (81) respectively (the first flex region [60] and second flex region [66] can be made of polycarbonate material while the first [80] and second compression elements [81] are elongated, flexible strips of adhesive tape made of Rayon woven tape: paragraph 0044/0059).
Regarding claim 19, Embodiment B of Blurton et al. discloses the invention as discussed in claim 18. Embodiment B of Blurton et al. further discloses wherein the compression surface apex (30) comprises a contact material (the compression surface apex [30] can be formed of silicone or any type of elastomeric material: paragraph 0044).
Regarding claim 20, Embodiment B of Blurton et al. discloses the invention as discussed in claim 19. Embodiment B of Blurton et al. further discloses wherein the respective materials of said first flex region (60) and said second flex region (66) each have a thickness thinner than said contact material (see annotated figure 4, the thickness of the first flex region [60] and second flex region [66] are thinner than the contact material that makes up the central support element [AA]).
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.
Claim 7 rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Blurton et al. (US 20070260163 A1) in view of Cox (US 5695484 A).
Regarding claim 7, Embodiment A of Blurton et al. discloses the invention as discussed in claim 4.
However, Embodiment A of Blurton et al. fails to disclose a medical grade foam disposed on a surface of said thin plastic substrate opposite said first and second surfaces continuously from the first distal end of the first compression element, across the central support element to the second distal end of the second compression element.
Cox teaches a medical grade foam (16 - see annotated figure 5, the body member [16] can be made of a polyurethane base foam or polyolefins with a biocompatible adhesive layer coated on the side that will make contact with the user: column 3, lines 28-43) disposed on a surface (H – see annotated figure 5, a surface of the thin plastic substrate) of an analogous thin plastic substrate (12 - see annotated figure 5, a polymeric adhesive layer coated that can extend over the entire front side of the body member [14 - see annotated figure 5], which will contact the user: column 2, lines 42-45 & column 3, lines 11-15 & 23-27) opposite an analogous first (I – see annotated figure 5, a first surface) and second surfaces (J – see annotated figure 5, a second surface) continuously from the first distal end of analogous first compression element (40 – see annotated figure 5, distal end of the first compression element), across an analogous central support element (13 - see annotated figure 5, an adhesive free area where the anal patch [10] will contact the anus: column 3, lines 23-27) to the second distal end of an analogous second compression element (40b – see annotated figure 5, distal end of the second compression element) (see annotated figure 5, the medical grade foam [16] is on a surface [H] of the thin plastic substrate [12] that is opposite of the first [I] and second surfaces [J] and is continuous from the first distal end [40], across the central support element [13], to the second distal end [40b]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a surface of the thin plastic substrate of Embodiment A of Blurton et al. with a medical grade foam that is continuous from the first distal end of the first compression element, across the central support element, and second distal end of the second compression element as taught by Cox in order to provide a perianal support device that has an improved surface of the substrate including the medical grade foam to improve mechanical properties of the device and promote maximum comfort to the wearer (column 1, lines 53-56/column 5, lines 61-65/column 6, lines 23-27, Cox).
Allowable Subject Matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 16 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Claims 5 and 12 would be allowable once a Terminal Disclaimer has been filed to overcome the nonstatutory double patenting rejection. The following is an examiner’s statement of reasons for allowance.
Claim 5 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 Embodiment A of Blurton et al. (US 20070260163 A1).
Embodiment A of Blurton et al. discloses the thin plastic substrate (300 – figure 18, a support device made of polycarbonate material: paragraph 0049) comprises a common substrate (figure 16, the thin plastic substrate [300] is one-piece).
However, none of the relevant prior art discloses 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 5 is allowable.
Claim 12 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 Embodiment A of Blurton et al. (US 20070260163 A1).
Embodiment A of Blurton et al. discloses the first compression element (530 – figure 19/figure 20, an elongated fixation member: paragraph 0049/0052), the first lateral extent (B – see annotated figure 2, a first lateral extent), second compression element (520 – figure 19/figure 20, an elongated fixation member: paragraph 0049/0052), and the second lateral extent (C – see annotated figure 2, a second lateral extent).
However, none of the relevant prior art discloses wherein the first compression element further comprises a first tab extending outwardly laterally from said first compression element, said first tab having a first lateral tab extent less than the first lateral extent, and wherein said second compression element further comprising a second tab extending outwardly from said second compression element, said second tab having a second lateral extent less than the second lateral extent. Therefore, claim 12 is allowable. Claim 13 would also be allowable due to its dependency on claim 12.
Claim 16 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 Embodiment A of Blurton et al. (US 20070260163 A1).
Embodiment A of Blurton et al. discloses gauze material (the first flex region [D], the second flex region [F], and compression surface apex [A] each comprise a portion of the central support element [410] that can be made of a gauze pad: paragraph 0047/0049), said first (D – see annotated figure 2, a first flex region) and second flex regions (F – see annotated figure 2, a second flex region), and said compression surface apex (A – see annotated figure 1, a compression surface apex).
However, none of the relevant prior art discloses wherein the gauze material of each of said first and second flex regions is thinner than the gauze material of said compression surface apex. Therefore, claim 16 is allowable.
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.”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5-8, 12, 14, 17, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 8, 15, 17-19, 21, and 24 of U.S. Patent No. 12329669. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant Application
US 12329669 B2
Claim 1: A perianal support device for use on a patient, comprising: a central support element comprising a compression surface apex dimensioned to extend across an anal orifice of the patient in a sagittal plane of the patient; a first compression element comprising a first resilient, flexible member configured to follow a first contour of a first buttock of the patient and a first surface facing the first buttock of the patient, the first surface having a first lateral extent configured to releasably attach to a first anchor pad placed on the first buttock; a second compression element comprising a second resilient, flexible member configured to follow a second contour of a second buttock of the patient and a second surface facing the second buttock of the patient, the second surface having a second lateral extent configured to releasably attach to a second anchor pad placed on the second buttock; a first flex region between a proximal end of said first compression element and said central support element; and a second flex region between a proximal end of said second compression element and said central support element.
Claim 1: A perianal support device for use on a patient, comprising: a central support element comprising a contact surface configured and dimensioned to extend across an anal orifice of the patient in a sagittal plane of the patient from an anterior portion posterior to a vaginal opening of the patient to a posterior portion posterior to the anal orifice of the patient; a first compression element extending from the central support element in a first lateral direction to a first distal end, the first compression element comprising a first surface configured to follow a first contour of a first buttock of the patient within a gluteal cleft of the patient, and releasably attach to a first anchor pad that is adapted to be placed across a first crown of the first buttock; a second compression element extending from the central support element in a second lateral direction to a second distal end, the second compression element comprising a second surface configured to follow a second contour of a second buttock of the patient within the gluteal cleft of the patient, and releasably attach to a second anchor pad that is adapted to be placed across a second crown of the second buttock; wherein the perianal support device comprises a resilient, flexible member comprising a continuous, unitary substrate extending continuously from the first distal end of the first compression element, across the central support element, to the second distal end of the second compression element, the first surface and the second surface being disposed on one side of the continuous, unitary substrate separated by the central support element; and wherein the perianal support device comprises a first loop material on the first surface, the first loop material comprising a loop portion of a first hook and loop fastener, and a second loop material on the second surface, the second loop material comprising a loop portion of a second hook and loop fastener.
Claim 18: A perianal support device for use on a patient, comprising: a central support element comprising a contact surface configured and dimensioned to extend across an anal orifice of the patient in a sagittal plane of the patient from an anterior portion posterior to a vaginal opening of the patient to a posterior portion posterior to the anal orifice of the patient; a first compression element extending from the central support element in a first lateral direction to a first distal end, the first compression element comprising a first surface configured to follow a first contour of a first buttock of the patient within a gluteal cleft of the patient, and releasably attach to skin of the first buttock; a second compression element extending from the central support element in a second lateral direction to a second distal end, the second compression element comprising a second surface configured to follow a second contour of a second buttock of the patient within the gluteal cleft of the patient, and releasably attach to skin of the second buttock; wherein the perianal support device comprises a resilient, flexible member comprising a substrate extending continuously from the first distal end of the first compression element, across the central support element, to the second distal end of the second compression element, the first surface and the second surface being disposed on one side of the substrate separated by the central support element; and wherein the perianal support device comprises a first adhesive on the first surface configured to releasably attach to skin of the first buttock, and a second adhesive on the second surface configured to releasably attach to skin of the second buttock.
Claim 25: The perianal support device of claim 18, wherein the first compression element has a lateral extent to extend across a crown of the first buttock and the second compression element has a lateral extent to extend across a crown of the second buttock when the central support element is placed across the anal orifice of the patient.
Independent Claim 1 Analysis
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 18, and 25 of U.S. Patent No. 12329669. Claims 1, 18, and 25 of U.S. Patent No. 12329669 recites the location and structure regarding the central support element, contact surface, first/second compression elements, first/second anchor pad, first/second surface, and lateral extents. Thus, the invention of claims 1, 18, and 25 of U.S. Patent No. 12329669 is a “species” of the “generic” invention of claim 1 of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the instant application is anticipated by claims 1, 18, and 25 of U.S. Patent No. 12329669, it is not patentably distinct from claims 1, 18, and 25 of U.S. Patent No. 12329669.
Claim 2: The perianal support device of claim 1, wherein: the first and second surfaces comprise a loop portion of a hook and loop fastener, the first and second anchor pads comprise a hook portion of the hook and loop fastener, and the first and second surfaces are configured to releasably attach to the first and second anchor pads, respectively, using the hook and loop fastener.
Claim 1: A perianal support device for use on a patient, comprising: a central support element comprising a contact surface configured and dimensioned to extend across an anal orifice of the patient in a sagittal plane of the patient from an anterior portion posterior to a vaginal opening of the patient to a posterior portion posterior to the anal orifice of the patient; a first compression element extending from the central support element in a first lateral direction to a first distal end, the first compression element comprising a first surface configured to follow a first contour of a first buttock of the patient within a gluteal cleft of the patient, and releasably attach to a first anchor pad that is adapted to be placed across a first crown of the first buttock; a second compression element extending from the central support element in a second lateral direction to a second distal end, the second compression element comprising a second surface configured to follow a second contour of a second buttock of the patient within the gluteal cleft of the patient, and releasably attach to a second anchor pad that is adapted to be placed across a second crown of the second buttock; wherein the perianal support device comprises a resilient, flexible member comprising a continuous, unitary substrate extending continuously from the first distal end of the first compression element, across the central support element, to the second distal end of the second compression element, the first surface and the second surface being disposed on one side of the continuous, unitary substrate separated by the central support element; and wherein the perianal support device comprises a first loop material on the first surface, the first loop material comprising a loop portion of a first hook and loop fastener, and a second loop material on the second surface, the second loop material comprising a loop portion of a second hook and loop fastener.
Claim 5: The perianal support device of claim 4, 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.
Claim 1: A perianal support device for use on a patient, comprising: a central support element comprising a contact surface configured and dimensioned to extend across an anal orifice of the patient in a sagittal plane of the patient from an anterior portion posterior to a vaginal opening of the patient to a posterior portion posterior to the anal orifice of the patient; a first compression element extending from the central support element in a first lateral direction to a first distal end, the first compression element comprising a first surface configured to follow a first contour of a first buttock of the patient within a gluteal cleft of the patient, and releasably attach to a first anchor pad that is adapted to be placed across a first crown of the first buttock; a second compression element extending from the central support element in a second lateral direction to a second distal end, the second compression element comprising a second surface configured to follow a second contour of a second buttock of the patient within the gluteal cleft of the patient, and releasably attach to a second anchor pad that is adapted to be placed across a second crown of the second buttock; wherein the perianal support device comprises a resilient, flexible member comprising a continuous, unitary substrate extending continuously from the first distal end of the first compression element, across the central support element, to the second distal end of the second compression element, the first surface and the second surface being disposed on one side of the continuous, unitary substrate separated by the central support element; and wherein the perianal support device comprises a first loop material on the first surface, the first loop material comprising a loop portion of a first hook and loop fastener, and a second loop material on the second surface, the second loop material comprising a loop portion of a second hook and loop fastener.
Claim 18: A perianal support device for use on a patient, comprising: a central support element comprising a contact surface configured and dimensioned to extend across an anal orifice of the patient in a sagittal plane of the patient from an anterior portion posterior to a vaginal opening of the patient to a posterior portion posterior to the anal orifice of the patient; a first compression element extending from the central support element in a first lateral direction to a first distal end, the first compression element comprising a first surface configured to follow a first contour of a first buttock of the patient within a gluteal cleft of the patient, and releasably attach to skin of the first buttock; a second compression element extending from the central support element in a second lateral direction to a second distal end, the second compression element comprising a second surface configured to follow a second contour of a second buttock of the patient within the gluteal cleft of the patient, and releasably attach to skin of the second buttock; wherein the perianal support device comprises a resilient, flexible member comprising a substrate extending continuously from the first distal end of the first compression element, across the central support element, to the second distal end of the second compression element, the first surface and the second surface being disposed on one side of the substrate separated by the central support element; and wherein the perianal support device comprises a first adhesive on the first surface configured to releasably attach to skin of the first buttock, and a second adhesive on the second surface configured to releasably attach to skin of the second buttock.
Claim 6: The perianal support device of claim 4, wherein the thin plastic substrate is configured in a generally V-shaped form.
Claim 2: The perianal support device of claim 1, wherein the continuous, unitary substrate is configured in a generally V-shaped form, the contact surface being disposed at an apex of the V-shaped form, the first compression element and the second compression element forming an internal angle of the V-shaped form, and comprising an inner surface interiorly of the V-shaped form and an outer surface exteriorly of the V-shaped form.
Claim 18: The perianal support device of claim 18, wherein the substrate is configured in a generally V-shaped form.
Claim 7: The perianal support device of claim 4, further comprising a medical grade foam disposed on a surface of said thin plastic substrate opposite said first and second surfaces continuously from the first distal end of the first compression element, across the central support element to the second distal end of the second compression element.
Claim 3: The perianal support device of claim 2, wherein a medical grade foam is disposed on the inner surface of the V-shaped form continuously from the first distal end of the first compression element, across the central support element to the second distal end of the second compression element.
Claim 17: The perianal support device of claim 1, wherein a medical grade foam is disposed on a side of the continuous, unitary substrate opposite the first surface and the second surface, the medical grade foam extending continuously from the first distal end of the first compression element, across the central support element to the second distal end of the second compression element.
Claim 19: The perianal support device of claim 18, wherein a medical grade foam is disposed on a side of the substrate opposite the first surface and the second surface, the medical grade foam extending continuously from the first distal end of the first compression element, across the central support element to the second distal end of the second compression element.
Claim 8: The perianal support device of claim 1, wherein the first and second compression elements comprise a first width adjacent to the central support element and a second width proximate to first and second distal ends of the respective first and second compression elements, the first width being less than the second width, a peripheral extent of each of the first and second compression elements being curved.
Claim 8: The perianal support device of claim 1, wherein the first and second compression elements each comprises a first width adjacent to the central support element and a second width proximate to the first and second distal ends of the respective first and second compression elements, the first width being less than the second width.
Claim 24: The perianal support device of claim 18, wherein the first and second compression elements each comprises a first width adjacent to the central support element and a second width spaced laterally from the first width, the first width and the second width having different dimensions from each other.
Claim 12: The perianal support device of claim 1, wherein the first compression element further comprises a first tab extending outwardly laterally from said first compression element, said first tab having a first lateral tab extent less than the first lateral extent, and wherein said second compression element further comprising a second tab extending outwardly from said second compression element, said second tab having a second lateral extent less than the second lateral extent.
Claim 15: The perianal support device of claim 1, further comprising a first tab extending from the first compression element and a second tab extending from the second compression element, the first and second tabs configured for gripping to manually attach the first and second surfaces to the first and second anchor pads, respectively.
Claim 21: The perianal support device of claim 18, further comprising a first tab extending from the first compression element and a second tab extending from the second compression element, the first and second tabs configured for gripping to manually attach the first and second surfaces to first and second anchor pads, respectively.
Claim 14: The perianal support device of claim 1, wherein the compression surface apex comprises a gauze material.
Claim 5: The perianal support device of claim 2, wherein the contact surface comprises a gauze pad.
Dependent Claims 2, 5-8, 12, and 14 Analysis
Claims 2, 5-8, 12, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 8, 15, 17-19, 21, and 24 of U.S. Patent No. 12329669. Claims 1-3, 5, 8, 15, 17-19, 21, and 24 of U.S. Patent No. 12329669 recites the location and structure regarding the first surface/second surface, hook and loop portions, a substrate, a medical grade foam, first width/ second width, first tab/second tab, and contact surface with gauze pad. Thus, the invention of claims 1-3, 5, 8, 15, 17-19, 21, and 24 of U.S. Patent No. 12329669 is a “species” of the “generic” invention of claims 2, 5-8, 12, and 14 of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 2, 5-8, 12, and 14 of the instant application is anticipated by claims 1-3, 5, 8, 15, 17-19, 21, and 24 of U.S. Patent No. 12329669, it is not patentably distinct from claims 1-3, 5, 8, 15, 17-19, 21, and 24 of U.S. Patent No. 12329669.
Claim 17: A perianal support device, comprising: a central support element comprising a compression surface apex dimensioned to extend across an anal orifice of a patient in a sagittal plane of the patient; a first compression element extending from the central support element in a first lateral direction, the first compression element comprising a first resilient, flexible member configured to follow a first contour of a first buttock of the patient, the first compression element further comprising a first surface comprising a first attachment feature facing the first buttock of the patient, and a second surface comprising a soft material facing away from the first buttock, a second compression element extending from the central support element in a second lateral direction opposite the first lateral direction, the second compression element comprising a second resilient, flexible member configured to follow a second contour of a second buttock of the patient, the second compression element further comprising a third surface comprising a second attachment feature facing the second buttock of the patient, and a fourth surface comprising the soft material facing away from the second buttock; a first flex region connected to said central support element and to a proximal end of said first compression element; and a second flex region connected to said central support element and to a proximal end of said second compression element.
Claim 1: A perianal support device for use on a patient, comprising: a central support element comprising a contact surface configured and dimensioned to extend across an anal orifice of the patient in a sagittal plane of the patient from an anterior portion posterior to a vaginal opening of the patient to a posterior portion posterior to the anal orifice of the patient; a first compression element extending from the central support element in a first lateral direction to a first distal end, the first compression element comprising a first surface configured to follow a first contour of a first buttock of the patient within a gluteal cleft of the patient, and releasably attach to a first anchor pad that is adapted to be placed across a first crown of the first buttock; a second compression element extending from the central support element in a second lateral direction to a second distal end, the second compression element comprising a second surface configured to follow a second contour of a second buttock of the patient within the gluteal cleft of the patient, and releasably attach to a second anchor pad that is adapted to be placed across a second crown of the second buttock; wherein the perianal support device comprises a resilient, flexible member comprising a continuous, unitary substrate extending continuously from the first distal end of the first compression element, across the central support element, to the second distal end of the second compression element, the first surface and the second surface being disposed on one side of the continuous, unitary substrate separated by the central support element; and wherein the perianal support device comprises a first loop material on the first surface, the first loop material comprising a loop portion of a first hook and loop fastener, and a second loop material on the second surface, the second loop material comprising a loop portion of a second hook and loop fastener.
Claim 18: A perianal support device for use on a patient, comprising: a central support element comprising a contact surface configured and dimensioned to extend across an anal orifice of the patient in a sagittal plane of the patient from an anterior portion posterior to a vaginal opening of the patient to a posterior portion posterior to the anal orifice of the patient; a first compression element extending from the central support element in a first lateral direction to a first distal end, the first compression element comprising a first surface configured to follow a first contour of a first buttock of the patient within a gluteal cleft of the patient, and releasably attach to skin of the first buttock; a second compression element extending from the central support element in a second lateral direction to a second distal end, the second compression element comprising a second surface configured to follow a second contour of a second buttock of the patient within the gluteal cleft of the patient, and releasably attach to skin of the second buttock; wherein the perianal support device comprises a resilient, flexible member comprising a substrate extending continuously from the first distal end of the first compression element, across the central support element, to the second distal end of the second compression element, the first surface and the second surface being disposed on one side of the substrate separated by the central support element; and wherein the perianal support device comprises a first adhesive on the first surface configured to releasably attach to skin of the first buttock, and a second adhesive on the second surface configured to releasably attach to skin of the second buttock.
Claim 25: The perianal support device of claim 18, wherein the first compression element has a lateral extent to extend across a crown of the first buttock and the second compression element has a lateral extent to extend across a crown of the second buttock when the central support element is placed across the anal orifice of the patient.
Independent Claim 17 Analysis
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 18, and 25 of U.S. Patent No. 12329669. Claims 1, 18, and 25 of U.S. Patent No. 12329669 recites the location and structure regarding the central support element, contact surface, first/second compression elements, and first/second surface. Thus, the invention of claims 1, 18, and 25 of U.S. Patent No. 12329669 is a “species” of the “generic” invention of claim 17 of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 17 of the instant application is anticipated by claims 1, 18, and 25 of U.S. Patent No. 12329669, it is not patentably distinct from claims 1, 18, and 25 of U.S. Patent No. 12329669.
Claim 19: The perianal support device of claim 18, wherein the compression surface apex comprises a contact material.
Claim 5: The perianal support device of claim 2, wherein the contact surface comprises a gauze pad.
Dependent Claim 19 Analysis
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12329669. Claim 5 of U.S. Patent No. 12329669 recites the location and structure regarding contact surface and its material. Thus, the invention of claim 5 of U.S. Patent No. 12329669 is a “species” of the “generic” invention of claim 19 of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 19 of the instant application is anticipated by claim 5 of U.S. Patent No. 12329669, it is not patentably distinct from claim 5 of U.S. Patent No. 12329669.
Conclusion
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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786