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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/10/2026 has been entered.
Response to Amendment
The amendment filed 09/10/2026 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, 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 (420, 8B); a reservoir (270C, Fig 6); an adhesive (166, Fig 9A) received within the reservoir; and one or more tubular fluid flow conduits (110, 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 is longer than it is wide. See annotated Fig 11B below that shows that the housing can be interpreted as a tubular conduit as it forms long hollow channels for conveying the adhesive) and configured to direct the adhesive to the skin of a patient on which the housing is arranged (Para 0047, 0051).
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 wings 122 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). The combined invention of Peterson and Chelak would result in the one or more tubular fluid flow conduits (122, Fig 2 of Peterson as modified by Chelak to comprise the channels and reservoirs) are arranged along a surface of the catheter adapter housing (120, Fig 2 of Peterson), and wherein at least a portion of each of the one or more tubular fluid flow conduits is positioned against and directly contacts the surface of the catheter adapter housing (As seen in Fig 1 and 2 of Peterson, the modified wings 122 that are being interpreted as the conduit are directly contacting the surface of the catheter adapter 120).
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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 reservoirs are on the wings 122, the wings and thus the reservoirs are on a surface of the catheter adapter housing as seen in Fig 1 of Peterson. This surface can be the upper surface as “upper” is relative to how the device is positioned).
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 (122, Fig 2 of Peterson as modified by Chelak to comprise the channels and reservoirs) comprise: a first fluid flow conduit (one of the wings 122) in fluid communication with the reservoir and arranged on an upper surface of the catheter adapter housing (as the reservoirs are on the wings 122, the wings and thus the reservoirs are on a surface of the catheter adapter housing as seen in Fig 1 of Peterson. This surface can be the upper surface as “upper” is relative to how the device is positioned), the first fluid flow conduit having a proximal end (portion of the wing opposite the portion of the wing nearest the end of the catheter adapter near the needle 110) adjacent the reservoir and a distal end (portion of the wing 122 nearest the end of the catheter adapter near the needle 110) 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 (122, Fig 2 of Peterson as modified by Chelak to comprise the channels and reservoirs) comprise: a second fluid flow conduit (one of the wings 122) in fluid communication with the reservoir and arranged about a lateral surface of the catheter adapter housing (See Fig 2 -Peterson), 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 annotated Fig 2); and a third fluid flow conduit (other one of wing 122) in fluid communication with the second fluid flow conduit (they are at least in fluid communication at the outlets 310, Fig 11A -Chelak), 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).
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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.
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 0060).
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 (110, 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 that the housing can be interpreted as a tubular conduit as it forms long hollow channels for conveying the adhesive) and configured to direct the adhesive to the skin of a patient on which the housing is arranged (Para 0047, 0051).
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). The combined invention of Tan and Chelak would result in the one or more tubular fluid flow conduits (42,44, Fig 2 of Tan as modified by Chelak to comprise the channels and reservoirs) are arranged along a surface of the catheter adapter housing (75, Fig 6, Para 0068 of Tan), and wherein at least a portion of each of the one or more tubular fluid flow conduits is positioned against and directly contacts the surface of the catheter adapter housing (Para 0055, the second section 20 including the wings 42,44 frictionally grip the catheter adapter housing).
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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, and wherein at least a portion of each of the one or more tubular fluid flow conduits is positioned against and directly contacts the 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).
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). The combined invention of Tan and Chelak would result in the one or more tubular fluid flow conduits (42,44, Fig 2 of Tan as modified by Chelak to comprise the channels and reservoirs) are arranged along a surface of the catheter adapter housing (75, Fig 6, Para 0068 of Tan), and wherein at least a portion of each of the one or more tubular fluid flow conduits is positioned against and directly contacts the surface of the catheter adapter housing (Para 0055, the second section 20 including the wings 42,44 frictionally grip the catheter adapter housing).
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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 Belson (US 2008/0300574).
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 09/10/2026, on pages 6-7, regarding Peterson, Tan, and Chelak failing to teach the amended limitations have been fully considered but are not persuasive. As detailed in the current rejection of the independent claims, the wings of Peterson and Tan modified by Chelak to comprise the channels and reservoirs are being interpreted as the conduits. Therefore, the conduits are positioned against and directly contacting the surface of the catheter adapter housing.
Conclusion
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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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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