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 01/27/2026 has been entered. Claims 1, 3-22 are pending in the application. Applicant’s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 10/21/2025.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-16, 18-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Albany (US 2018/0177982).
Regarding Claim 1, Albany discloses a catheter assembly (1201, Fig 12B), comprising: a catheter adapter (1209, Fig 12B) comprising a proximal end, a distal end, and a lumen extending along a first longitudinal axis (central longitudinal axis of catheter 1209) therebetween; a catheter extending from the distal end of the catheter adapter (Para 0129); a dressing (1205 Fig 12B) comprising a first end proximate to the proximal end, a second end proximate to the distal end, and first and second sides extending therebetween (See annotated Fig 12B), the dressing defining a second longitudinal axis (longitudinal axis defined by pegs 1405, Fig 14E) and configured to cover at least a portion of the catheter adapter at a site of penetration into a patient's vasculature (Para 0129), the dressing further comprising an upper surface (Surface near numeral 1423, Fig 14E) and a lower surface (Surface near numeral 1401, Fig 14A), the lower surface configured to contact skin of a patient (A patient can touch the surface at numeral 1401 if the cover 1403 is removed); and a tourniquet (one of straps 1211, Fig 12B) configured to apply a radially-inward pressure to a limb of a patient near the site of penetration (Para 0138); and one or more arms (1207, Fig 12B) extending from the tourniquet, wherein the tourniquet is attached beyond the second end, and wherein the one or more arms extend over the second end (See Fig 12A) and are configured to couple with the dressing along at least one of the first or second sides of the dressing (Para 0154; the arm 1207 couples to the dressing via pins 1405).
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Regarding Claim 3, Albany discloses the one or more arms (1207, Fig 12B) are configured to be coupled with the dressing at one or more locations along the arms (Para 0154).
Regarding Claim 4, Albany discloses the dressing further comprises one or more pegs (1405, Fig 14E) arranged on the upper surface (See Fig 14E)
Regarding Claim 5, Albany discloses the one or more pegs (1405, Fig 14E) are arranged along the second longitudinal axis of the dressing, the second longitudinal axis being parallel to the first longitudinal axis (See Fig 12A).
Regarding Claim 6, ,Albany discloses the one or more pegs (1405, Fig 14E) comprise at least one peg arranged along the first side and at least one peg arranged along the second side (See Fig 14E)
Regarding Claim 7, Albany discloses the one or more arms (1207, Fig 12A) are configured to releasably couple to the one or more pegs (Para 0154; the pegs 1405 releasably couples to recesses 1515 on arm 1207).
Regarding Claim 8, Albany discloses the one or more arms (1207, Fig 12A) comprise a plurality of openings (1515, Fig 15C), the openings configured to releasably couple to the one or more pegs (Para 0154).
Regarding Claim 9, Albany discloses the one or more arms (1207, Fig 12A) extend from the tourniquet at a plurality of locations (See Fig 12A; the arm 1207 extends from the tourniquet from a plurality of points along the tourniquet).
Regarding Claim 10, Albany discloses the one or more arms (1207, Fig 12A) are coupled with the dressing at a single location (Para 0169; the arm is coupled to the dressing along the lip 1423).
Regarding Claim 11, Albany discloses the one or more arms (1207, Fig 12B) comprises a tensioning assembly (1215, Fig 12B) (Para 0129; the straps allows the arm 1207 to be fastened or tensioned to the patient).
Regarding Claim 12, Albany discloses the one or more arms (1207, Fig 12A) couple to the dressing adjacent the proximal end of the catheter adapter (Para 0169; the arm is coupled to the dressing along the lip 1423 which is adjacent to both the distal and proximal end of the catheter adapter).
Regarding Claim 13, Albany discloses the one or more arms (1207, Fig 12A) couple to the dressing adjacent the distal end of the catheter adapter (Para 0169; the arm is coupled to the dressing along the lip 1423 which is adjacent to both the distal and proximal end of the catheter adapter).
Regarding Claim 14, Albany discloses the one or more arms (1207, Fig 12A) are formed of a flexible material (Para 0184, the arm can be made of rubber).
Regarding Claim 15, Albany discloses the one or more arms (1207, Fig 12A) are formed of an elastomeric material (Para 0184, the arm can be made of rubber).
Regarding Claim 16, Albany discloses the one or more arms are formed of a rigid material (Para 0184; as rigid is a relative term, arm 1207 can be considered to have some rigidity, especially compared to a liquid material).
Regarding Claim 18, Albany discloses an enclosure (1203, Fig 12B) configured to cover at least a portion of the catheter adapter (Para 0139).
Regarding Claim 19, Albany discloses the tourniquet comprises a fastener (1219, Fig 12B) configured to allow the tourniquet to be shortened and lengthened, thereby allowing differing amounts of radially-inward pressure to be applied to the patient's limb (Para 0137, Para 0138).
Regarding Claim 20, Albany discloses a second tourniquet (See annotated Fig 12B copied below) configured to apply a radially-inward pressure to a limb of a patient near the site of penetration, the second tourniquet configured to couple with the dressing (Para 0137-0138; the straps can be used as tourniquets and at least indirectly coupled to the dressing as shown in Fig 12C and described in Para 0137).
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Regarding Claim 21, Albany discloses the second tourniquet comprises one or more second arms (strap 1211 is an arm that at least indirectly couples with the dressing) configured to couple with the dressing (Para 0137; “an underside securement portion 1219 of the full-length fastening strap 1211 can secure to at least a portion of the hub component 1207 and an underside securement portion 1219 can also secure to an exterior securement portion 1221 of the full-length fastening strap 1211”).
Regarding Claim 22, Albany discloses a catheter assembly (1201, Fig 12B), comprising: a catheter adapter (1209, Fig 12B) comprising a proximal end, a distal end, and a lumen extending along a first longitudinal axis (central longitudinal axis of catheter 1209) therebetween; a catheter extending from the distal end of the catheter adapter (Para 0129); a dressing (1205 Fig 12B) comprising a first end proximate to the proximal end, a second end proximate to the distal end, and first and second sides extending therebetween (See annotated Fig 12B), the dressing defining a second longitudinal axis (longitudinal axis defined by pegs 1405, Fig 14E) and configured to cover at least a portion of the catheter adapter at a site of penetration into a patient's vasculature (Para 0129), the dressing further comprising an upper surface (Surface near numeral 1423, Fig 14E) and a lower surface (Surface near numeral 1401, Fig 14A), the lower surface configured to contact skin of a patient (A patient can touch the surface at numeral 1401 if the cover 1403 is removed); a tourniquet (one of straps 1211, Fig 12B) configured to apply a radially-inward pressure to a limb of a patient near the site of penetration (Para 0138); and one or more arms (1207, Fig 12B) extending from the tourniquet, wherein the tourniquet is attached beyond the second end, and wherein the one or more arms extend over the second end (See Fig 12A) and are configured to couple with the dressing between the distal end of the catheter and the first end of the dressing (Para 0154; the arm 1207 couples to the dressing via pins 1405 which is between the distal end of the catheter and the first end annotated in the Fig 12B below).
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Claims 1, 3, 9, 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Price (US 2016/0106958).
Regarding Claim 1, Price discloses a catheter assembly (device of Fig 6) comprising: a catheter adapter (9, Fig 1) comprising a proximal end, a distal end, and a lumen extending along a first longitudinal axis therebetween; a catheter extending from the distal end of the catheter adapter (Para 0079); a dressing (120, 160, Fig 6) comprising a first end proximate to the proximal end, a second end proximate to the distal end, and first and second sides extending therebetween, the dressing defining a second longitudinal axis (central longitudinal axis of dressing) and configured to cover at least a portion of the catheter adapter at a site of penetration into a patient's vasculature (See Fig 6), the dressing further comprising an upper surface (surface of dressing 120 opposite the skin contacting surface) and a lower surface (skin contacting surface of dressing 120), the lower surface configured to contact skin of a patient; and a tourniquet (103, Fig 6) configured to apply a radially-inward pressure to a limb of a patient near the site of penetration; and one or more arms (102, 109, Fig 14) extending from the tourniquet, wherein the tourniquet is attached beyond the second end (See Fig 9; the tourniquet 103 is attached beyond the second end at least in the lateral direction), and wherein the one or more arms extend over the second end (See annotated Fig 6) and are configured to couple with the dressing along at least one of the first or second sides of the dressing (Couples with at least release arm 109a of penetration closure 160 as described in Para 0100. As seen in annotated Fig 6, the release arm falls within both the first and second sides).
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Regarding Claim 3, Price discloses the one or more arms (102, 109, Fig 14) are configured to be coupled with the dressing at one or more locations along the arms (they are coupled with the dressing through release arm 109a, Para 0100).
Regarding Claim 9, Price discloses the one or more arms (102, 109, Fig 14) are connected to a main body of the tourniquet at a plurality of locations (As seen in Figs 10 and 14, the arms 102 and 109 are coupled to the tourniquet 103 at multiple locations at least through the teeth of the dial 106; Para 0098).
Regarding Claim 11, Price discloses the one or more arms (102, 109, Fig 14) comprise a tensioning assembly (106, Fig 14; Para 0098)
Regarding Claim 16, Price discloses the one or more arms (102, 109, Fig 14) are formed of a rigid material (As seen in Fig 14 and described in Para 0100, the arms must be rigid to actuate the release arm 109 and release the belt).
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 17 is rejected under 35 U.S.C. 103 as being unpatentable over (US 2016/0106958) in view of Marais (US 4,316,461).
Regarding Claim 17, Price discloses all of the elements of the invention as discussed above, however, is silent regarding the dressing comprises an adhesive arranged on the lower surface.
Marais teaches an analogous dressing (10, Fig 1) configured to cover at least a portion of the catheter adapter (44, Fig 7) at a site of penetration into a patient's vasculature (See Fig 7), the dressing further comprising an upper surface and a lower surface; wherein the dressing comprises an adhesive (30, Fig 2) arranged on the lower surface (Col 2, lines 54-56).
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 dressing to have adhesive material on a lower surface as taught by Marais in order to ensure that the central slot is aligned with the vein (Col 2, line 57- Col 3, line 1).
Response to Arguments
Applicant’s arguments filed 01/27/2026, on pages 7-9, regarding Albany failing to disclose the amended limitations have been fully considered but are not persuasive. While the current rejection still relies on Albany, the interpretation is significantly different such that it reads on the new limitations. As detailed the rejection above, the lock component 1205 is being interpreted as the claimed dressing and the hub component 1207 is being interpreted as the one or more arms. This allows for an interpretation where these elements meet all of the limitations of the claimed dressing and one or more arms.
Applicant’s arguments filed 01/27/2026, on pages 9-10, regarding Price failing to teach any sort of coupling that occurs either along at least one of a first or second side of the penetration closure have been fully considered but are not persuasive. As shown in the annotated Fig 6, the first and second sides are being interpreted a left half and right half of the dressing. The claim does not specify what the sides must include. Under this interpretation, the arms couple with at least the release arm 109a of penetration closure 160 as described in Para 0100 and the release arm falls within both the first and second sides.
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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