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 .
Response to Amendment
The amendment filed 02/13/2026 has been entered. Claims 1-6, 8-12, 14-15 are pending in the application.
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 1-7, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson (US 2013/0150791) in view of Chelak (US 2021/0236777).
Regarding Claim 1, Peterson discloses a catheter adapter (100, Fig 4), comprising: a housing (120,122, Fig 4) having a proximal end, a distal end, a lumen arranged between and in fluid communication with the distal end and the proximal end (Para 0021); a catheter (110, Fig 4) arranged at the distal end of the catheter adapter and in fluid communication with the lumen (Para 0003).
Peterson is silent regarding a reservoir; an adhesive received within the reservoir; and one or more tubular fluid flow conduits in fluid communication with the reservoir and configured to direct the adhesive to the skin of a patient on which the catheter adapter is arranged, wherein the one or more tubular fluid flow conduits are arranged along a surface of the catheter adapter housing.
Chelak teaches a housing (110, Fig 6) having wings; a reservoir (270C, Fig 6); an adhesive (166, Fig 9A) received within the reservoir; and one or more tubular fluid flow conduits (300, Fig 9A) in fluid communication with the reservoir (the Oxford English Dictionary defines tube as “A hollow body, usually cylindrical, and long in proportion to its diameter, of wood, metal, glass, or other material, used to convey or contain a liquid or fluid, or for other purposes; a pipe”. Therefore, a tube does not necessarily need to be cylindrical and only needs to be a hollow conduit that in longer than it is wide. See annotated Fig 11B below that shows ) and configured to direct the adhesive to the skin of a patient on which the housing is arranged (Para 0047, 0051), wherein the one or more tubular fluid flow conduits are arranged along a surface of the adapter (As best seen in Figs 10A and described in Para 0047, there are multiple fluid paths 300 along the length of the housing 110 for each pouch 270 to prevent fluid 166 from becoming trapped between the pouches 270A-D and the housing. At least the conduits associated with pouches 270B and 270C would be arranged along a surface of the adapter 420,seen in Fig 8B, as they are parallel to the surface of the adapter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the adhesive portion on the housing with adhesive and adhesive remover in reservoirs on the wings of the housing in order to have a less cumbersome device that can aid in more accurate placement and facilitate securement and removal of the device (Para 0003-0004).
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Regarding Claim 2, the modified invention of Peterson and Chelak discloses the reservoir (270D, Fig 6 -Chelak) is arranged on an upper surface of the catheter adapter housing (as the wings are a part of the housing and the reservoir is arranged on an upper surface of the wings, it is arranged on an upper surface of the housing).
Regarding Claim 3, the modified invention of Peterson and Chelak discloses the reservoir is formed of a compressible material (Para 0045 -Chelak).
Regarding Claim 4, the modified invention of Peterson and Chelak discloses the reservoir is formed of a resilient material (Para 0045 -Chelak).
Regarding Claim 5, the modified invention of Peterson and Chelak discloses the one or more fluid flow conduits (300, Fig 9A -Chelak) comprise: a first fluid flow conduit (one of the conduits leading from reservoir 270C) in fluid communication with the reservoir and arranged on an upper surface of the catheter adapter housing (at least a portion of the first fluid flow conduit is arranged on an upper surface of the wing/housing), the first fluid flow conduit having a proximal end (proximal wall of conduit 300 near the reservoir -Chelak) adjacent the reservoir and a distal end (distal wall of conduit 300 -Chelak) adjacent the distal end of the catheter adapter housing, wherein the first fluid flow conduit is configured to direct the adhesive to a location where the catheter pierces the skin of the patient (Para 0051 -Chelak).
Regarding Claim 6, the modified invention of Peterson and Chelak discloses the one or more fluid flow conduits (300, Fig 9A -Chelak; See Para 0047 and Fig 10A wherein each reservoir has multiple conduits and outlets) comprise: a second fluid flow conduit (another one of the conduits leading from reservoir 270C) in fluid communication with the reservoir and arranged about a lateral surface of the catheter adapter housing (the conduits are near a side of the housing/wing), the second fluid flow conduit having a proximal end arranged on an upper surface of the catheter adapter housing and adjacent the reservoir and a distal end adjacent a bottom surface of the catheter adapter housing (See Fig 9A -Chelak); and a third fluid flow conduit (yet another one of the conduits leading from reservoir 270C) in fluid communication with the second fluid flow conduit (they are at least in fluid communication through the shared reservoir 270C), the third fluid flow conduit extending along an outer surface of the catheter adapter housing parallel to a longitudinal axis defined by the catheter adapter lumen (the third fluid conduit at least has a dimension that extends parallel to the longitudinal axis), the third fluid flow conduit having one or more openings configured to direct the adhesive to the skin of the patient (Para 0051 -Chelak).
Regarding Claim 13, the modified invention of Peterson and Chelak discloses the reservoir (270D, Fig 6 -Chelak) is arranged on an upper surface of the housing (as the wings are a part of the housing and the reservoir is arranged on an upper surface of the wings, it is arranged on an upper surface of the housing).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson (US 2013/0150791) in view of Chelak (US 2021/0236777) and further in view of Tan (US 2017/0246429).
Regarding Claim 9, the modified invention of Peterson and Chelak discloses all of the elements of the invention as discussed above, however, is silent regarding the reservoir and/or the one or more fluid flow conduits are welded to the catheter adapter housing.
Tan teaches a housing (20, Fig 2) having wings (42, 44, Fig 2) wherein the wings are welded to the housing (Para 0063, lines 42-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wings to be welded to the base as Tan teaches that welding the wings to the base and forming the base and wings as a one-piece structure could be used to achieve the same result (provide a device that can fit to the patient as detailed in Para 0063, lines 31-45) and thus were art-recognized equivalents at the time the invention was made. It has been held that substituting parts of an invention involves only routine skill in the art.
Examiner notes that since the reservoirs and conduits of the combined invention would be on the wings, and the wings in view of Tan are welded to the housing, the reservoir and conduits are at least indirectly welded to the housing.
Claims 1, 8, 11, 12, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Tan (US 2017/0246429) in view of Chelak (US 2021/0236777).
Regarding Claim 1, Tan discloses a catheter adapter (120, Fig 1B), comprising: a housing (75, Fig 1B) having a proximal end, a distal end, a lumen arranged between and in fluid communication with the distal end and the proximal end (Para 0002); a catheter (76, Fig 1B) arranged at the distal end of the catheter adapter and in fluid communication with the lumen (Para 0002); and a stabilization element (20, Fig 2) having wings (42,44, Fig 2) for securing the catheter hub to the patient (Para 0067).
Tan is silent regarding a reservoir; an adhesive received within the reservoir; and one or more tubular fluid flow conduits in fluid communication with the reservoir and configured to direct the adhesive to the skin of a patient on which the catheter adapter is arranged, wherein the one or more tubular fluid flow conduits are arranged along a surface of the catheter adapter housing.
Chelak teaches a housing (110, Fig 6) having wings; a reservoir (270C, Fig 6); an adhesive (166, Fig 9A) received within the reservoir; and one or more tubular fluid flow conduits (300, Fig 9A) in fluid communication with the reservoir (the Oxford English Dictionary defines tube as “A hollow body, usually cylindrical, and long in proportion to its diameter, of wood, metal, glass, or other material, used to convey or contain a liquid or fluid, or for other purposes; a pipe”. Therefore, a tube does not necessarily need to be cylindrical and only needs to be a hollow conduit that in longer than it is wide. See annotated Fig 11B below that shows ) and configured to direct the adhesive to the skin of a patient on which the housing is arranged (Para 0047, 0051), wherein the one or more tubular fluid flow conduits are arranged along a surface of the adapter (As best seen in Figs 10A and described in Para 0047, there are multiple fluid paths 300 along the length of the housing 110 for each pouch 270 to prevent fluid 166 from becoming trapped between the pouches 270A-D and the housing. At least the conduits associated with pouches 270B and 270C would be arranged along a surface of the adapter 420,seen in Fig 8B, as they are parallel to the surface of the adapter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the adhesive pad 46 on the stabilization element 20 with adhesive and adhesive remover in reservoirs on the wings of the stabilization element in order to have a less cumbersome device that can aid in more accurate placement and facilitate securement and removal of the device (Para 0003-0004).
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Regarding Claim 8, the modified invention of Tan and Chelak discloses the reservoir and/or the one or more fluid flow conduits are arranged on the catheter adapter housing by a press-fit or a friction fit (Para 0055, lines 1-5 -Tan; the modified invention would have the reservoir and conduits on the stabilization element 20 that is friction fit to the housing).
Regarding Claim 11, the modified invention of Tan and Chelak discloses the catheter adapter housing comprises one or more grooves (grooves of the T shaped element that engage with the slot 55 of the stabilization element; Para 0069 -Tan) configured to receive at least a portion of the reservoir and/or the one or more fluid flow conduits.
Regarding Claim 12, the modified invention of Tan and Chelak discloses the reservoir is spaced from an upper surface of the catheter adapter housing (See Fig 6 -Tan; as the reservoir of the modified invention is on one of the wings 42,44, the wings and thus the reservoir are spaced from the upper surface of the housing 75 as seen in the figure).
Regarding Claim 14, Tan discloses a kit comprising: a catheter adapter (120, Fig 1B) having a housing (75, Fig 1B) having a proximal end, a distal end, a lumen arranged between and in fluid communication with the distal end and the proximal end (Para 0002), a catheter (76, Fig 1B) arranged at the distal end of the catheter adapter and in fluid communication with the lumen (Para 0002); a stabilization element (20, Fig 2) having wings (42,44, Fig 2) for securing the catheter hub to the patient (Para 0067); and a packaging (“Plastic wrap”) defining an interior, the catheter adapter received within the packaging interior (Para 0054; Para 0057, lines 1-6).
Tan is silent regarding a reservoir; an adhesive received within the reservoir; and one or more tubular fluid flow conduits in fluid communication with the reservoir and configured to direct the adhesive to the skin of a patient on which the catheter adapter is arranged, wherein the one or more tubular fluid flow conduits are arranged along a surface of the catheter adapter housing.
Chelak teaches a housing (110, Fig 6) having wings; a reservoir (270C, Fig 6); an adhesive (166, Fig 9A) received within the reservoir; and one or more tubular fluid flow conduits (300, Fig 9A) in fluid communication with the reservoir (the Oxford English Dictionary defines tube as “A hollow body, usually cylindrical, and long in proportion to its diameter, of wood, metal, glass, or other material, used to convey or contain a liquid or fluid, or for other purposes; a pipe”. Therefore, a tube does not necessarily need to be cylindrical and only needs to be a hollow conduit that in longer than it is wide. See annotated Fig 11B below that shows ) and configured to direct the adhesive to the skin of a patient on which the housing is arranged (Para 0047, 0051), wherein the one or more tubular fluid flow conduits are arranged along a surface of the adapter (As best seen in Figs 10A and described in Para 0047, there are multiple fluid paths 300 along the length of the housing 110 for each pouch 270 to prevent fluid 166 from becoming trapped between the pouches 270A-D and the housing. At least the conduits associated with pouches 270B and 270C would be arranged along a surface of the adapter 420,seen in Fig 8B, as they are parallel to the surface of the adapter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the adhesive pad 46 on the stabilization element 20 with adhesive and adhesive remover in reservoirs on the wings of the stabilization element in order to have a less cumbersome device that can aid in more accurate placement and facilitate securement and removal of the device (Para 0003-0004).
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Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson (US 2013/0150791) in view of Chelak (US 2021/0236777) and further in view of Tan (US 2017/0246429) and further in view of Baid (US 2020/0121896).
Regarding Claim 10, the modified invention of Peterson, Chelak, and Tan discloses the reservoir and/or the one or more fluid flow conduits are welded to the catheter adapter housing, however, is silent regarding it being tack welded or laser welded.
Baid teaches attaching portions of a catheter adaptor together via laser welding (Para 0084).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter adaptor to be laser welded as laser welding is a common means to assemble catheter adaptors (Para 0084).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Tan (US 2017/0246429) in view of Chelak (US 2021/0236777) and further in view of .
Regarding Claim 15, the modified invention of Tan and Chelak discloses all of the elements of the invention as discussed above, however, is silent regarding the catheter adapter and/or the packaging are sterilized.
Belson teaches a catheter and packaging that are sterilized (Para 0027).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter adapter and packaging to be sterilized as taught by Belson in order to ensure sterility of the device before use (Para 0027).
Response to Arguments
Applicant’s arguments filed 02/13/2026, on page 6, regarding Chelak failing to teach tubular fluid flow conduits arranged along a surface of the catheter adapter housing have been fully considered but is not persuasive. As detailed above, tubular does not necessarily require a conduit to be cylindrical. Examiner recommends specifying the shape of the fluid flow conduits. Applicant states that the fluid paths 300 are merely shallow recesses or openings, however, as shown in the annotated Fig 11B of Chelak, they meet the definition of a tube having a longer proportion that the width. The claim does not provide any particular length required for the conduits. Regarding the fluid flow conduits arranged along a surface of the catheter adapter housing, Figs 10A shows and Para 0047 describes that there are multiple fluid paths 300 along the length of the housing 110 for each pouch 270 to prevent fluid 166 from becoming trapped between the pouches 270A-D and the housing. At least the conduits associated with pouches 270B and 270C would be arranged along a surface of the adapter 420, seen in Fig 8B, as they are parallel to the surface of the adapter. This is sufficient to read on the claim language. Examiner recommends specifying that fluid flow conduits are directly contacting the catheter adaptor housing or that the longitudinal axis of conduits are parallel with the longitudinal axis of the catheter adaptor housing.
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 ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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