DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
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.
Claim(s) 1, 2 and 7- 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200330733 A1 to Howell in view of US 20150305739 A1 to Rolandi et al. (Rolandi).
Regarding claim 1:
Howell discloses:
A securement device (figure 1a-1b) for securing a medical article (310) having at least one medical line (300) insertable into a skin (50) of a user at an insertion site (¶0044), the securement device comprising:
a main body (100) comprising:
a first major surface (see the first major surface A in figure 1 below);
a second major surface (see the surface B in figure 1 below) opposite to the first major surface (as shown in figure 1 below), wherein the second major surface is configured to face the skin of the user (as shown in figure 1 below);
a perimeter (see the perimeter C in figure 1 below) extending between the first major surface and the second major surface (as shown in figure 1 below); and
a slot (portions 116A and 116B define the slot) extending from the perimeter and extending through the main body (100) from the first major surface to the second major surface (as shown in figure 3a), wherein the slot is configured to at least partially and slidably receive the at least one medical line therethrough (as shown in figure 3a);
a clip (220) coupled to the main body (100) and extending from the first major surface, wherein the clip (220) is configured to at least partially receive the medical article therethrough and removably secure the medical article to the main body (100) (¶0043); and
an adhesive layer (124; ¶0042) coupled to the main body (100) and extending from the second major surface (as shown in figure 1B).
Howell fails to disclose:
A plurality of microhooks coupled to the main body and extending from the second major surface, wherein the plurality of microhooks are spaced apart from each other and configured to be at least partially inserted into the skin of the user to secure the main body to the skin, wherein each microhook from the plurality of microhooks comprises a base disposed on the second major surface and a tip distal to the base, wherein the plurality of microhooks comprises at least one microhook and at least one opposing microhook facing the at least one microhook, such that the respective tips of the at least one microhook and the at least one opposing microhook point towards each other.
Rolandi teaches:
A securement device (figure 13c) with a first and second major surface (top and bottom of device in 13c) that includes two different microhooks/microneedles (see arrays D and E in figure 2 below). Further, the arrays are arranged to point toward each other (as shown in figure 13d). further, the reference teaches microhooks/microneedles can be used as substitutes for adhesives to avoid allergic reactions to adhesives (¶0003).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Howell to replace the adhesive layer in Howell with microhooks/needles as taught by Rolandi to protect the user from an allergic reaction to adhesives (Rolandi, ¶0003). This would result in microhooks on parts 110B and 110A (surface B as shown in figure 1 below) of Howell which would point toward each other in the same manner in Rolandi in figure 13d.
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Figure 1 – figure 1B of Howell, annotated by the examiner
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Figure 2 -figures 13c and 13d of Rolandi, annotated by the examiner
Regarding claim 2:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 1, wherein the second major surface (B in figure 1 above of Howell) defines a surface centroid (see centroid at axis 90 as shown in figure 1c of Howell), wherein the plurality of microhooks (see the microhooks of Rolandi incorporated into Howell) comprises at least one first microhook, and wherein the tip of the at least one first microhook points towards the surface centroid (the microhooks of Rolandi would be incorporated onto surfaces B in figure 1 above of 110A and 110B that would point toward each other and the centroid of 90 in the same manner shown in Rolandi).
Regarding claim 7:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 3, wherein the set of first microhooks comprises at least two first microhooks disposed diametrically opposite to each other, such that the respective tips of the at least two first microhooks point towards each other (the microhooks of Rolandi incorporated into Howell would be arranged as a set on the surface B in the figure 1 above on 110A and 110B which would point toward each other).
Regarding claim 8:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 3, wherein the set of first microhooks comprises at least one first microhook (microhooks from Rolandi incorporated into Howell would be arranged on surface B of 110A and 110B and would point toward each other and the slot of Howell) disposed opposite to the slot (116A and 116B), such that the tip of the at least one first microhook points towards the slot (116A and 116B).
Regarding claim 9:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 3, wherein the set of first microhooks comprises at least two first microhooks (microhooks from Rolandi incorporated into Howell would be arranged on surface B of 110A and 110B and would point toward each other and the slot of Howell) disposed on opposing sides of the slot (116A and 116B ).
Regarding claim 10:
Howell discloses:
The securement device of claim 2, wherein the slot (116A and 116B) linearly extends from the perimeter (C in figure 1 above) towards the surface centroid (see centroid at axis 90 as shown in figure 1c of Howell) of the second major surface (as shown in figure 1c).
The slot (portions 116A and 116B define the slot) and that the slot is sized to receive the pad/disc (60)(¶0068). The reference further teaches the pad/disc can have different sizes based on the needs of the patient (¶0047). This teaches the slot size is a results effective variable dependent on the size of the pad/disc required.
Howell fails to disclose:
The securement device of claim 2, wherein the slot linearly extends from the perimeter towards the surface centroid of the second major surface, such that a length of the slot is from about 30% to about 50% of a maximum length of the main body.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Howell to make the slot 30% to about 50% of a maximum length of the main body the slot size is a results effective variable dependent on the size of the pad/disc used for the patient.
Regarding claim 11:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 1, wherein the plurality of microhooks comprises a set of second microhooks arranged in a pair of rectangular arrays (microhooks from Rolandi incorporated into Howell would be arranged on surface B of 110A and 110B and would point toward each other and the slot of Howell) disposed on opposing sides of the slot (116A and 116B ), and wherein the tip of each second microhook from the set of second microhooks points towards the slot (116A and 116B ).
Regarding claim 12:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 1, wherein the second major surface (B in figure 1 above of Howell) defines at least one line of symmetry (90 of Howell), wherein the plurality of microhooks comprises a set of third microhooks arranged in a pair of rectangular arrays disposed on opposing sides of the line of symmetry, wherein the tip of each third microhook from the set of third microhooks points towards the line of symmetry (the original set of microhook arrays of Rolandi incorporated onto surfaces B of 110A and 110B can be arbitrarily divided into first, second and third sets of arrays that point toward each other across the line of symmetry 90).
Regarding claim 13:
Howell fails to disclose:
The securement device of claim 1, wherein at least 50% of an area of the second major surface is devoid of the plurality of microhooks.
Rolandi teaches:
The securement device can have a space/isthmus/area between arrays that can be any suitable length (¶0009; ¶0083). Further, the spacing/isthmus is sized to span the would indicating that it is a results effective variable depending on the size or locations that the device needs to span.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Howell to make the at least 50% of an area of the second major surface is devoid of the plurality of microhooks since the area devoid of microhooks is a results effective dependent on the size of the area that the securement device needs to span on the patient.
Regarding claim 14:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 1, wherein the base (see the base F in figure 3 below of the microhook of Rolandi incorporated into Howell) defines a base plane, a base area in the base plane (plane at F in figure 3 below), and a base centroid (centroid G of plane at F in figure 3 below) of the base area, and wherein an imaginary line (imaginary line H in figure 3 below) joining the tip and the base centroid is inclined obliquely to the base plane (as shown in figure 3 below).
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Figure 3 - figure 2b of Rolandi, annotated by the examiner
Regarding claim 15:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 14, wherein the imaginary line (H in figure 3 above) is inclined obliquely to the base plane by an inclination angle from about 20 degrees to about 70 degrees (51 degrees as indicated in figure 2b).
Regarding claim 16:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 14, wherein each microhook defines a hook axis extending from the base centroid to the tip along a length thereof, and wherein the hook axis is curvilinear or linear (linear as shown by line H in figure 3 above).
Regarding claim 17:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 14, wherein the tip of each microhook points away from the base, such that an imaginary vertical line extending from the tip normal to the base plane lies outside the base (see the direction of tip of the microhook as shown in figure 3 above which points away from the base).
Regarding claim 18:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 1, wherein at least one microhook from the plurality of microhooks has a square cross-sectional shape (see the square cross-sectional shape of the hooks as shown in figure 5c of Rolandi and incorporated into Howell accordingly).
Regarding claim 19:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 1, wherein each microhook from the plurality of microhooks defines a height between the base and the tip, and wherein the height is from about 300 microns (µm) to about 600 µm (¶0141 of Rolandi which teaches the microhooks can have a height of 1 µm to 3mm which would be incorporated into Howell accordingly).
Regarding claim 20:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 1, wherein each microhook from the plurality of microhooks has a solid configuration devoid of channels (as shown in figure 5c of Rolandi and incorporated into Howell accordingly).
Regarding claim 21:
Howell discloses:
The securement device of claim 1, wherein the main body (100) has an elastic modulus from about 0.1 megapascals (MPa) to about 1000 MPa (polyurethane as indicated in ¶0073 which the applicants disclosure indicates on page 7, lines 1-10 can an elastic modulus in this range).
Regarding claim 22:
Howell discloses:
The securement device of claim 1, wherein the main body comprises at least one of polyurethane (main body can include polyurethane as indicated in ¶0073), neoprene, polyester, butyl rubber, silicone, and polymer foam.
Regarding claim 23:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Howell and Rolandi:
The securement device of claim 1, wherein each of the plurality of microhooks comprises at least one of stainless steel, carbon-fiber-reinforced polymer, poly(methyl methacrylate) (¶0017 in Rolandi and incorporated into Howell accordingly), dissolvable polyester, nickel alloy, and titanium alloy.
Regarding claim 24:
Howell discloses:
The securement device of claim 1, wherein the main body (100) is substantially rectangular (see the rectangular shape of the main body 100 as shown in figure 1a) with rounded corners (see the rounded corners of 110b and 110a as shown in figure 1a).
Claim(s) 25 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200330733 A1 to Howell in view of US 20150305739 A1 to Rolandi et al. (Rolandi) as applied to claim 1 above, and further in view of US 20090125002 A1 to Totz.
Regarding claim 25:
Howell and Rolandi fail to disclose:
The securement device of claim 1, wherein the clip comprises:
a clip base coupled to the main body and extending from the first major surface of the main body;
a split ring resiliently coupled to the clip base, the split ring comprising a first ring portion proximal to the clip base, a second ring portion distal to the clip base and comprising an outer ring surface facing away from the first ring portion, and a plurality of locking teeth extending from the outer ring surface, and wherein the split ring is configured to at least partially receive the medical article therethrough; and
a locking arm resiliently coupled to and extending from the clip base, wherein the locking arm comprising a plurality of detents corresponding to a plurality of predetermined widths of the split ring;
wherein the second ring portion is resiliently movable relative to the locking arm in a first direction, and wherein each detent from the plurality of detents is configured to selectively and lockingly engage with a corresponding locking tooth from the plurality of locking teeth in order to prevent the second ring portion from moving in a second direction opposite to the first direction.
Totz teaches:
A securement device (figure 12) that includes:
a clip base (921);
a split ring (see portions I and J in figure 1 below) resiliently coupled to the clip base, the split ring comprising a first ring portion (see portion I in figure 4 below) proximal to the clip base, a second ring portion (see the second portion J in figure 4 below) distal to the clip base and comprising an outer ring surface (920) facing away from the first ring portion, and a plurality of locking teeth (920) extending from the outer ring surface, and wherein the split ring is configured to at least partially receive the medical article therethrough (in 923); and
a locking arm (926/918) resiliently coupled to and extending from the clip base, wherein the locking arm comprising a plurality of detents (920b and 918b) corresponding to a plurality of predetermined widths (plurality of gaps between teeth 920) of the split ring;
wherein the second ring portion (see the second portion J in figure 4 below) is resiliently movable relative to the locking arm in a first direction (moves into the cavity between 918a and 926), and wherein each detent from the plurality of detents (918b and 920b) is configured to selectively and lockingly engage with a corresponding locking tooth (each of 920) from the plurality of locking teeth (920) in order to prevent the second ring portion (see the second portion J in figure 4 below) from moving in a second direction opposite to the first direction (prevents J from moving away from the cavity between 926 and 918a).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Howell and Rolandi to replace the clip in Howel with the clip including the clip base, split ring and locking arm as taught by Totz. This is a simple substitution of one known element (clip in Howell) for another (clip in Totz) to obtain predictable results (to secure the medical article to the securement device).
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Figure 4 – figure 12 of Totz, annotated by the examiner
Regarding claim 26:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 25 by Howell, Rolandi and Totz:
The securement device of claim 25, wherein each locking tooth (see the teeth of Totz incorporated into Howell) comprises a tooth curved surface (see the curved surface K in figure 5 below of Totz) and a tooth planar surface (see the planar surface L in figure 5 below of Totz) opposite to the tooth curved surface, wherein each detent comprises a detent curved surface (see the curved surface L in figure 5 below of Totz) and a detent planar surface (see the curved surface M in figure 5 below of Totz), wherein the tooth curved surface is configured to movably engage with the detent curved surface to allow movement of the second ring portion in the first direction (as shown in figure 9B of Totz), and wherein the tooth planar surface is configured to lockingly engage with the detent planar surface to prevent the second ring portion to move in the second direction (preventing it from disengaging from the 918 of Totz).
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Figure 5– figure 13 of Totz, annotated by the examiner
Allowable Subject Matter
Claims 4-6 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20160158523-A1
Helm
See the main body 112
US-20210252256-A1
Berenson
See the main body 260
US-20170333039-A1
Leung
See the microhooks 130
US-20080243082-A1
Goodman
See the main body 12
WO-2007117655-A2
BIERMAN
See the main body 100
KR-20210050604-A
KIM
See the main body 1100
WO-2023042047-A1
LAWSON
See the microhooks 121
WO-2016044753-A1
HUIZENGA
See mounts 134
WO-9533508-A1
KORNERUP
See the main body 1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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