DETAILED ACTION
This is a final rejection in response to amendments filed 6/15/2026. Claims 1, 3-8, 11, 14, 29, 31 34-35, and 38-39 are currently pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-8, 11, 14, 29, 31 34-35, and 38-39 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 31 objected to because of the following informalities: claim depends on canceled claim 30, claim should depend on claim 29. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1,6-8, 14, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall et al. (US 4516968) in view of Dickert et al. (US 2012/0109069).
Regarding independent claim 1, 14 and 29, Marshall teaches a securement device comprising: a base 12 having a first major surface and an opposing second major surface, the base defining a through cavity sized to receive a portion of a catheter assembly (col. 2, l. 44-68), wherein the base defines a first slit 22; and a casing 18 including a wall, wherein the casing defines a volume in communication with the through cavity, wherein the casing is configured (i) to receive a lumen of the catheter assembly in a hole in the wall of the casing, and (ii) such that the lumen is movable through the first slit and a second slit in the casing extending to the hole and positionable in the hole (col. 2, l. 44-68).
Marshall is silent to an adhesive layer on the base to secure the base to skin of a user. Additionally, Marshall teaches a first slit but is silent to a second slit. Marshall is also silent to the catheter’s specific parts, albeit the listed structure would be considered inherent.
Dickert teaches a flexibly base member 12 having an adhesive side 14 configured to secure the base member to a patient’s skin [0027] and a slit disposed between straps of an anchoring member mounted between the anchoring structure and the base structure. Furthermore, Dickert confirms the parts of a catheter assembly [0005].
It would have been obvious to one of ordinary skill in the art at the time of filing to modify Marshall’s shield to provide an adhesive layer on the flange/base region, as taught by Dickert, and form two slits as two aligned as communicating slit segments, one int the base region and one in the casing region extending to the catheter hole, as Dickert teaches a slit into a pocket access structure. Dickert teaches such a combination would allow for secure attachment with easy removability of catheter without damaging catheter or insertion site [0005].
Regarding dependent claim 6, Marshall in view of Dickert teaches the invention as claimed and discussed above. Marshall further teaches wherein the material of the casing is transparent or translucent (col. 3, l. 30-32).
Regarding dependent claim 7, Marshall in view of Dickert teaches the invention as claimed and discussed above. Marshall further teaches wherein the material of the casing comprises at least one is made of a shape memory polymeric material a thermoformed plastic material or a combination thereof (col. 2, l. 29-33).
Regarding dependent claim 8, Marshall in view of Dickert teaches the invention as claimed and discussed above. Marshall further teaches wherein the casing further comprises a rim attached to the first major surface of extending between the wall and the base.
Claim(s) 3-4 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall in view of Dickert and further in view of Burn (US 2009/0143741).
Regarding dependent claim 3 and 31, Marshall in view of Dickert teaches the invention as claimed and discussed above. Dickert further teaches the base with an adhesive layer as well as pull tabs [0030].
Marshall in view of Dickert however fails to teach the adhesive is directly attached to the skin.
Burn teaches wherein the base further comprises one or more pull tabs disposed at a perimeter of the base and free of the adhesive layer, and wherein the one or more pull tabs are configured to be gripped to detach the base from the skin [0059,0075].
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Marshall in view of Dickert to have the base further comprises one or more pull tabs disposed at a perimeter of the base and free of the adhesive layer, and wherein the one or more pull tabs are configured to be gripped to detach the base from the skin as taught by Burn, as Burn teaches a more easily applied and removed device while reducing risk of catheter dislodgement [0082-0083].
Regarding dependent claim 4, Marshall in view of Dickert and further in view of Burn teaches the invention as claimed and discussed above. Burn further teaches wherein the adhesive layer comprises a stretch release adhesive [0048].
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall in view of Dickert and further in view of Riedel et al. (US 5092323).
Regarding dependent claim 5, Marshall in view of Dickert teaches the invention as claimed and discussed above. Marshall and Dickert teaches a base that is stiff but flexible but Marshall in view of Dickert is silent to wherein the base further comprises is made of a stretchable polymeric material.
Riedel teaches wherein the base further comprises is made of a stretchable polymeric material (col. 4, l. 17-24).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Marshall in view of Dickert to the base further comprises is made of a stretchable polymeric material as taught by Riedel, as Riedel teaches the material is occlusive of particulates and bacteria while being able to transmit water vapor and gases such as oxygen and carbon dioxide (col. 4, l. 17-24).
Claim(s) 11 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall in view of Dickert and further in view of Erskine et al. (US 5738664).
Regarding dependent claim 11 and 34, Marshall in view of Dickert teaches the invention as claimed and discussed above. Marshall and Dickert teaches a base that is stiff but flexible but Marshall in view of Dickert is silent to wherein, upon insertion of a needle of a syringe for injection of an anti-microbial gel within the casing, the casing forms a self-healing aperture to receive the needle therethrough.
Erskine teaches wherein the casing 26 comprises a material having a self-healing property (col. 3, l. 50-60), such that: the casing at least partially ruptures to receive at least one lumen of the catheter assembly therethrough (col. 3, l. 50-60); and upon receiving the at least one lumen of the catheter assembly therethrough, the casing forms a seal around the at least one lumen (col. 3, l. 60 – col. 5, l.4).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Marshall in view of Dickert to have the casing with a self-healing material as taught by Erskine, as Erskine teaches a sterile barrier and fluid seal even after repeated lumen insertion and removals, and preventing infections and improved reliability and safety (col. 1, l. 59 – col. 2, l. 14, and col. 5, l. 5-14).
Claim(s) 35 and 38-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall in view of Dickert and further in view of Bierman (US 2008/0027394).
Regarding dependent claim 35 and 38-39, Marshall in view of Dickert teaches the invention as claimed and discussed above. Marshall teaches a casing 18 having a wall and a crown opposite the peripheral flange 12 and defining a cavity. Marshall in view of Dickert is silent to a pin extending from the upper covering, wherein the pin is configured to inhibit movement of the catheter assembly based on the catheter assembly being arranged within the volume.
Bierman teaches a retainer 120 forming a channel 140 that receives a portion of a medical article (including a protuberance), to inhibit movement of the catheter assembly [0009,0060]
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Marshall in view of Dickert to have a case with a pin to inhibit movement of the catheter assembly based on the catheter assembly being arranged within the volume, as taught by Bierman, as Bierman teaches a safe and releasable securement to the skin of a patient [0007,0177].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG SANG KIM whose telephone number is (571)270-1418. The examiner can normally be reached 7:00 AM - 3:00 PM.
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/CRAIG KIM/
Primary Examiner
Art Unit 3741
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