DETAILED ACTION
This is a non-final rejection in response to application filed 1/25/2024. Claims 1-11,14-15, and 29-35 are currently pending.
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) 1-2, 5-11, 14, 29, 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Sullivan et al. (WO 2018138324) in view of Erskine et al. (US5738664).
Regarding independent claim 1 and 14 and 29 and dependent claim 33, O’Sullivan teaches a securement device for securing a catheter assembly, the securement device comprising: a base 1 having a first major surface and an opposing second major surface, the base defining a through cavity (see fig. 1) extending from the first major surface to the second major surface, wherein the base is configured to be detachably secured to a skin of a user (pg. 12, l. 20-25) such that an injection site associated with the catheter assembly is disposed within the through cavity (pg. 17, l. 16-31), and wherein the through cavity receives at least a portion of the catheter assembly therein (pg. 20, l. 34-pg. 21, l. 10); and
a casing 21 mounted on the first major surface of the base and enclosing the through cavity and the catheter assembly, wherein the casing is configured to engage with the catheter assembly to secure the catheter assembly within the through cavity (pg. 22, l. 23-pg. 23, l. 7),
O’Sullivan is silent to wherein the casing comprises a material having a self-healing property, such that: the casing at least partially ruptures to receive at least one lumen of the catheter assembly therethrough; and upon receiving the at least one lumen of the catheter assembly therethrough, the casing forms a seal around the at least one lumen.
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 O’Sullivan 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).
Regarding dependent claim 2, O’Sullivan in view of Erskine teaches the invention as claimed and discussed above. O’Sullivan further teaches comprising an adhesive layer at least partially disposed on the second major surface of the base and configured to detachably secure the base to the skin of the user (pg. 10, l. 23 – pg. 11, l. 8).
Regarding dependent claim 5, O’Sullivan in view of Erskine teaches the invention as claimed and discussed above. O’Sullivan further teaches wherein the base further comprises a stretchable polymeric material (silicone pg. 4, l. 10).
Regarding dependent claim 6, O’Sullivan in view of Erskine teaches the invention as claimed and discussed above. O’Sullivan further teaches wherein the material of the casing is transparent or translucent (pg. 5, l. 21).
Regarding dependent claim 7, O’Sullivan in view of Erskine teaches the invention as claimed and discussed above. Erskine further teaches wherein the material of the casing comprises at least one of a shape memory polymeric material and a thermoformed plastic material (col. 3, l. 51-60).
Regarding dependent claim 8, O’Sullivan in view of Erskine teaches the invention as claimed and discussed above. O’Sullivan further teaches wherein the casing further comprises a rim attached to the first major surface of the base (cover 21 attaches along perimeter).
Regarding dependent claim 9, O’Sullivan in view of Erskine teaches the invention as claimed and discussed above. O’Sullivan further teaches wherein the base further comprises a first slit 8 extending between a perimeter of the base and the rim.
Regarding dependent claim 10 and 32, O’Sullivan in view of Erskine teaches the invention as claimed and discussed above. O’Sullivan further teaches wherein the rim comprises at least one second slit,such that the first slit and the at least one second slit allow receipt of the at least one lumen within the casing (page 20, l. 1-26).
Regarding dependent claim 11 and 34, O’Sullivan in view of Erskine teaches the invention as claimed and discussed above. Erskine further teaches 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 (col. 4, l. 39-48).
Regarding dependent claim 35, O’Sullivan in view of Erskine teaches the invention as claimed and discussed above. O’Sullivan further teaches further comprising engaging the at least one lumen with one or more guide pins 24a of the casing.
Claim(s) 3-4, 15, and 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Sullivan in view of Erskine and further in view of Burn (US 2009/0143741).
Regarding dependent claim 3 and 15 and 30-31, O’Sullivan in view of Erskine teaches the invention as claimed and discussed above. O’Sullivan in view of Erskine is silent to 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.
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 O’Sullivan in view of Erskine 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, O’Sullivan in view of Erskine 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].
Conclusion
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