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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4 May 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 4 May 2025. As directed by the amendment: claims 1, 6, 11, and 16 have been amended. Thus claims 1-16 are presently pending in this application, and claims 6-10 remain withdrawn. Applicant’s amendments to the Claims have overcome each 35 U.S.C. 112(b) rejection previously set forth in the Final Office Action mailed 27 March 2025.
Response to Arguments
Applicant's arguments filed 4 May 2025 have been fully considered but they are not persuasive.
Applicant argues in Remarks that the finger grip of Boyaval is not the finger tab as claimed because the finger grip does not provide for placement of a finger to leverage against the surface to which the apparatus for managing wired is adhered, as does applicants. Instead, what is discloses in Boyaval is a grip for holding the device of Boyaval from both sides so the fingers do not slip over the device of Boyaval, requiring pressure from both sides. Such finger-to-finger pressure is difficult to exert when the device is elongated.
The examiner respectfully disagrees that the claim limitations of the finger tab are not taught by Boyaval. The finger grips of Boyaval have the same structure as that of the instant application but with a shallower and taller recess. The finger grips of Boyaval do provide space for a finger and a user could use one finger to leverage against the surface to which it is applied. This method is not described by Boyaval but it is possible. Placing a finger on the surface of the recess and leveraging against the surface the device is adhered to with enough force would remove the device.
Applicant indicates Claim 11 has the limitation of “a body that is planar” and refers to applicant’s Fig 7 showing a device that is relatively flat and lies on a plane. While this is not framed as an argument, the examiner notes the description of planar does not require the device to be relatively flat and lie on a plane. Instead, the device of Lowry meets the limitation as is has planar surfaces.
On page 5 of Remarks, Applicant cites Claim 11 as reciting “wherein the height of the body is greater than the width of the body.” However, the examiner notes this limitation is not claimed.
Further on pages 5 and 6, Applicant argues the width shown by the examiner is not the width of the device of Lowry, only the width of a small part of this device, however Claim 16 is amended to state total width and total height. The examiner disagrees that the previously cited width was not a width of the device, however, the amended limitations now require a new interpretation of the width and height and the examiner has annotated these at the largest of each dimension.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Claim 1 recites “the surface on which the body is installed” in line 11 and “the surface” in lines 14, 16-17, and twice in line 19. These should instead recite “the surface of the sterile field” as there are other surfaces claimed.
Claim 11 recites “a space between a portion of the back side” in line 17. This should instead recite “the back surface”. The examiner notes the back side was used in claim 1, but changed to back surface in claim 11.
Claim 11 recites “the portion of a finger” in lines 18-19. This should instead recite “the portion of the finger”.
Claim 11 recites “the surface” in line 19. This should instead recite “the surface of the sterile field” as there are other surfaces claimed.
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 11-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Lowry (US 2009/0005794 A1) in view of Boyaval et al. (US 2020/0261643 A1).
Regarding claim 1, Lowry discloses an apparatus (10 Fig 3) for managing wires ([0021] “The materials can include […] wires”) in a sterile field (As shown in Fig 4), the apparatus comprising: a body (18 Fig 1A) having a plurality of slots (22 Fig 1A) on a front side of the body (upper surface 26 Fig 1A); an adhesive material ([0025] “the lower surface 24 can include an attachment in the form of an adhesive region 30”) disposed on a back side of the body (24 Fig 1A) for temporarily adhering the body to a surface of the sterile field ([0025] “adhesive region 30 to temporarily secure the flexible member managing device 10 to the patient's skin or on a surface in the immediate vicinity of the surgical site”); whereas the adhesive material provides for adhesion to the surface ([0026]-[0027]) and removal from the surface by way of lifting the body using the finger tab ([0025] “The adhesive region can be a multiple-use adhesive such that the flexible member managing device 10 can be positioned and repositioned as needed. For example, the flexible member managing device 10 can be attached to a first location, easily removed from the first location, and then attached to a second location” the device is fully capable of being lifted by gripping the sides and pulling up).
However, Lowry fails to disclose a finger tab formed on the back side of the body, next to a side surface of the body, the finger tab configured to accept a finger for facilitating removal of the body from the surface on which the body is installed, the finger tab has a space between a portion of the back side and the surface of the sterile field when the apparatus for managing wires is adhered to the surface, the space is configured for inserting part of a finger to provide leverage when removal of the body from the surface is performed.
Boyaval et al. teaches a finger tab (208 Fig 3) formed on the back side of the body (the tab 208 is recessed into the back side by the amount spaced from the dashed line in annotated Fig 3, [0036] “side grips 208 include elongated recesses molded into the housing 106 at a location adjacent the bottom surface of the housing 206” the recesses provide a space where the bottom surface is not attached to the skin and “the side grips 208 of this embodiment are located adjacent to the bottom surface of the injector 202”), next to a side surface of the body (the recess is formed within and next to the side surface as shown in Fig 3), the finger tab configured to accept a finger for facilitating removal of the body from the surface on which the body is installed ([0036] “this arrangement can enable a user to more easily insert his/her fingers between the injector 202 and the patient's skin to assist with removal.”, 208 is configured to accept a portion of a finger for facilitating removal), the finger tab has a space between a portion of the back side and the surface (see the space shaded in gray in annotated Fig 3 below, the surface of the recess is a portion of the back side) when the apparatus is adhered to the surface, the space is configured for inserting part of a finger to provide leverage when removal of the body from the surface is performed (leverage would be provided when a user grips the regions 208 and lifts the device). It would have been obvious to one of ordinary skill in the art at the time of effective filing to include the finger tab of Boyaval et al. in the apparatus of Lowry to enable a user to more easily insert his/her fingers between the device and the patient's skin to assist with removal [0036].
Regarding claim 2, modified Lowry discloses the apparatus for managing wires of claim 1, wherein the body is made of silicone ([0023] “The flexible member managing device 10 can be made of any biocompatible material. Exemplary materials include, but are not limited to silicone”).
Regarding claim 3, modified Lowry discloses the apparatus for managing wires of claim 1, wherein the adhesive material is selected from a group consisting of an adhesive pad, a plurality of adhesive pads (strips 30 shown in Fig 2), a continuous sheet of adhesive, and an adhesive coating [0026].
Regarding claim 4, modified Lowry discloses the apparatus for managing wires of claim 1, wherein the adhesive material is one or more suction cups ([0027] “The adhesive region 30 can utilize a mechanical adhesion, such as that from a suction cup”).
Regarding claim 11, Lowry discloses a wire manager (10 Fig 3) for managing wires ([0021] “The materials can include […] wires”) in a sterile field (As shown in Fig 4), the wire manager comprising: a body (18 Fig 1A) that is planar (although there are two curved surfaces, the top, bottom, and all sides have flat planes as shown in Fig 3) and has a total width, a depth, and a total height (these dimensions can be measured at multiple positions of the device, the examiner is measuring at the positions shown in Annotated Fig 3); an adhesive ([0025] “the lower surface 24 can include an attachment in the form of an adhesive region 30”) disposed on a back surface of the body (24 Fig 1A) for temporarily adhering the body to a surface of the sterile field ([0025] “adhesive region 30 to temporarily secure the flexible member managing device 10 to the patient's skin or on a surface in the immediate vicinity of the surgical site”); a plurality of slots (22 Fig 1A) on a front surface of the body (upper surface 26 Fig 1A), each of the plurality of slots is sized for accepting a loop of wire (See the wire in Fig 3 in the slots, these slots are fully capable of accepting looped wire); whereas the adhesive is strong enough to keep the wire manager from moving when the wire manager is on the surface of the sterile field ([0026]-[0027]) and the adhesive is weak enough for removal of the wire manager from the surface of the sterile field without damaging the wire manager ([0025] “The adhesive region can be a multiple-use adhesive such that the flexible member managing device 10 can be positioned and repositioned as needed. For example, the flexible member managing device 10 can be attached to a first location, easily removed from the first location, and then attached to a second location” the device is fully capable of being lifted by gripping the sides and pulling up).
However, Lowry fails to disclose a finger tab formed on the back surface of the body and next to a side surface of the body, the finger tab configured to accept at least a portion of a finger for facilitating removal of the wire manager from the surface of the sterile field to which the wire manager is adhered, the finger tab provides a space between a portion of the back side and the surface of the sterile field for providing leverage by inserting at least the portion of a finger when removal of the body from the surface is performed.
Boyaval et al. teaches a finger tab (208 Fig 3) formed on the back surface of the body (the tab 208 is recessed into the side and bottom by the amount spaced from the dashed line in annotated Fig 3, [0036] “side grips 208 include elongated recesses molded into the housing 106 at a location adjacent the bottom surface of the housing 206” the recesses provide a space where the bottom surface is not attached to the skin and “the side grips 208 of this embodiment are located adjacent to the bottom surface of the injector 202”) and next to a side surface of the body (the recess is formed within and next to the side surface as shown in Fig 3), the finger tab configured to accept at least a portion of a finger for facilitating removal of the device from the surface to which the device is adhered ([0036] “this arrangement can enable a user to more easily insert his/her fingers between the injector 202 and the patient's skin to assist with removal.”, 208 is configured to accept a portion of a finger for facilitating removal), the finger tab provides a space between a portion of the back side and the surface of the sterile field (see the space shaded in gray in annotated Fig 3 below, the surface of the recess is a portion of the back side) for providing leverage by inserting at least the portion of a finger when removal of the body from the surface is performed (leverage would be provided when a user grips the regions 208 and lifts the device). It would have been obvious to one of ordinary skill in the art at the time of effective filing to include the finger tab of Boyaval et al. in the apparatus of Lowry to enable a user to more easily insert his/her fingers between the device and the patient's skin to assist with removal [0036].
Regarding claim 12, modified Lowry discloses the wire manager of claim 11, wherein the body is made of silicone ([0023] “The flexible member managing device 10 can be made of any biocompatible material. Exemplary materials include, but are not limited to silicone”).
Regarding claim 13, modified Lowry discloses the wire manager of claim 11, wherein the adhesive is selected from a group consisting of an adhesive pad, a plurality of adhesive pads (strips 30 shown in Fig 2), a continuous sheet of adhesive, and an adhesive coating [0026].
Regarding claim 15, modified Lowry discloses the wire manager of claim 11, wherein the adhesive material is at least one suction cup ([0027] “The adhesive region 30 can utilize a mechanical adhesion, such as that from a suction cup”).
Regarding claim 16, modified Lowry discloses the wire manager of claim 11. Lowry et al. further discloses wherein the total height of the body between the front surface and the back surface is less than the total width of the body between any opposing side surfaces (See annotated Fig 3, the total height is less than the total width).
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Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lowry (US 2009/0005794 A1) in view of Boyaval et al. (US 2020/0261643 A1) and Sieracki et al. (US 2022/0355078 A1).
Regarding claim 5, modified Lowry discloses the apparatus for managing wires of claim 1. However, modified Lowry is silent to wherein the adhesive material is pressure sensitive acrylate.
Sieracki et al. teaches an adhesive material is pressure sensitive acrylate ([0038] “The pressure sensitive adhesive is usually reasonably skin compatible and “hypoallergenic”, such as the acrylate copolymers”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the adhesive of modified Lowry to be a pressure sensitive acrylate as it is “usually reasonably skin compatible and ‘hypoallergenic’” [0038].
Regarding claim 14, modified Lowry discloses the wire manager of claim 11. However, Lowry is silent to wherein the adhesive material is pressure sensitive acrylate.
Sieracki et al. teaches an adhesive material is pressure sensitive acrylate ([0038] “The pressure sensitive adhesive is usually reasonably skin compatible and “hypoallergenic”, such as the acrylate copolymers”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the adhesive of modified Lowry to be a pressure sensitive acrylate as it is “usually reasonably skin compatible and ‘hypoallergenic’” [0038].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Vargas whose telephone number is (571)270-3873. The examiner can normally be reached Mon-Fri 5:00 PM-11:00 PM EST.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783