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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 6, 2026 has been entered.
Status of Claims
Amendments filed July 6, 2026 have been entered.
Claims 1 and 18 have been amended.
Claim 14 has been canceled.
Claims 1-13 and 15-20 are pending.
Response to Arguments
Applicant's arguments filed July 6, 2026 have been fully considered but they are not persuasive.
Applicant argues that Albany fails to teach or suggest “wherein the base comprises a minimum distance marker and a maximum distance marker corresponding to a minimum distance and a maximum distance, respectfully, between the distal end of the catheter adapter received on the support surface and an insertion site of the catheter, the minimum distance marker and the maximum distance marker defining a range of positions of the base relative to the insertion site configured to minimize an S-curve in the catheter,” as recited in amended independent claims 1 and 18. However, Examiner respectfully disagrees. Albany teaches markers 1527 disposed on either side of opening 1525, wherein the markers help a caregiver position and align hub component 1207 over an insertion site and provide an indication as to where a needle should be inserted into a patient. A person of ordinary skill in the art would have understood that the two markers 1527 define positional boundaries for placement of the base relative to the insertion site, such that the base and associated catheter adapter are positioned within a guided range relative to the insertion site.
Although the Applicant characterizes the claimed markers as a “minimum distance marker” and a “maximum distance marker,” the prior art is not required to use identical terminology to teach or suggest the claimed limitation. The relevant inquiry is whether the prior art teaches or suggests the claimed structure and function. Here, Albany’s pair of markers 1527 are arranged on the pad in substantially the same manner and serve substantially the same placement-guidance function as the claimed markers by indicating a positional range for the device relative to the insertion site.
Further, the recitation that the minimum distance marker and maximum distance marker define a range of positions of the base relative to the insertion site “configured to minimize an S-curve in the catheter” does not patently distinguish over the prior art combination because controlling the position of the catheter adapter/base relative to the insertion site affects the catheter path between the adapter and the insertion site. A person of ordinary skill in the art would have recognized that guiding placement of the base within a defined positional range, as taught by Albany’s markers 1527, would predictably minimize undesirable bending, slack, or curvature in the catheter, including an S-curve.
Accordingly, the amended language merely assigns different nomenclature and intended-result language to placement markers already taught or suggested by Albany and does not define a structural distinction patentably differentiating the claimed invention from the prior art. Therefore, Applicant’s arguments have been considered but are not persuasive, and the rejections of independent claims 1 and 18 under 35 U.S.C. §103 are maintained.
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.
Claims 1-13 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Spitler (US Patent No 11,925,776) hereinafter Spitler, in view of Bierman (US Patent No 9,895,514), hereinafter Bierman, and further in view of Albany (US Publication No 2018/0177982), hereinafter, Albany.
Regarding claim 1, Spitler discloses:
A stabilization device (securement system 300 in Fig. 18, Col 13, Lines 19-20) for a catheter, comprising:
A base (anchor pad 310 in Fig. 18, Col 13, Lines 20-22, 48-52) defining a base perimeter (boundary of anchor pad 310), the base comprising a top surface (upper surface 312 in Fig. 20, Col 13, Lines 55-61) and a bottom surface (lower surface 314 in Fig. 20, Col 13, Lines 55-61).
A support surface (retainer 320 in Fig. 18, Col 13, Lines 19-23) arranged on the top surface (upper surface 312) of the base (anchor pad 310), the support surface comprising a wall (raised portions 340a-b in Fig. 19, Col 14, Lines 20-24) extending away from the top surface of the base (anchor pad 310) and defining a support surface perimeter (boundary of retainer 320 in Fig. 19), the support surface perimeter having substantially the same shape as a catheter adapter (medical article 20 in Fig. 18); and
wherein at least one of the support surface (retainer 320 in Figs. 18-19) and the wall (raised portions 340a-b in Fig. 19) define a pocket configured to receive the catheter adapter (retainer 320 including: main semicylindrical channels 326 and 328, central channel 354, and side channel 356 form a pocket that is configured to receive central body 30 and outwardly extending member 50 of medical article 20 as shown in figs. 18-19), and
Spitler does not disclose a dressing defining a dressing perimeter, the dressing configured to cover the base (anchor pad 310) and the support surface (retainer 320).
Bierman, however, teaches a catheter dressing (cover dressing 114 in Figs. 9-10) which is used to cover a catheter assembly (Col 6, Lines 35-44), the perimeter of which is defined by the boundary of the cover dressing.
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 securement system of Spitler to add the transparent cover dressing taught by Bierman in order to enhance stability of the catheter securement system and increase visibility at the insertion site of the catheter.
Modified Spitler does not disclose that the base comprises a minimum distance marker and a maximum distance marker corresponding to a minimum distance and a maximum distance, respectively, between a distal end of the catheter adapter received on the support surface and an insertion site of the catheter, the minimum distance marker and the maximum distance marker defining a range of positions of the base relative to the insertion site configured to minimize an S-curve in the catheter.
Albany, however, teaches that the base comprises a minimum distance marker and a maximum distance marker (Albany: markers 1527 in Fig. 15C) corresponding to a minimum distance and a maximum distance, respectively, between a distal end of the catheter adapter received on the support surface and an insertion site of the catheter, the minimum distance marker and the maximum distance marker defining a range of positions of the base relative to the insertion site configured to minimize an S-curve in the catheter (Albany: markers 1527 provide an alignment indication as to where a needle should be inserted into a patient in Fig. 15C; para [0178]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Spitler to add alignment markers on both sides of the cutout as taught by Albany in order to aid caretakers in determining optimal insertion location of a catheter and predictably minimize undesirable bending, slack, or curvature in the catheter, including an S-curve.
Regarding claim 2, modified Spitler discloses the stabilization device (securement system 300) of claim 1 with a wall (raised portions 340a-b), but modified Spitler fails to disclose the material of which the wall is comprised.
Bierman teaches walls (front wall 82 and back wall 84 in Figs. 3 and 13) that are made of an extruded piece of foam (Col 7, Lines 11-13).
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 wall of Spitler to be comprised of foam material, as taught by Bierman, in order to provide improved conformability, compressibility, cushioning, and pressure distribution at the interface of the catheter adapter and the support surface.
Regarding claim 3, modified Spitler discloses the stabilization device (securement system 300) of claim 1, wherein the wall (raised portions 340a-b) comprises a first opening (semicylindrical channel 326 in Fig. 19) configured to receive a component of a catheter adapter (medical article 20) therein.
Regarding claim 4, modified Spitler discloses the stabilization device (securement system 300) of claim 3, wherein the wall (raised portions 340a-b) comprises a second opening (side channel 356 in Figs. 19, 28) configured to receive a component of the catheter adapter (medical article 20) therein.
Regarding claim 5, modified Spitler discloses the stabilization device (securement system 300) of claim 4, wherein the second opening (side channel 356 in Figs. 19, 28) is arranged at an angle selected from the group consisting of about 25 degrees, 45 degrees, 90 degrees, and 135 degrees (Col 6, Lines 43-48; outwardly extending portion 50 forms roughly a 45 degree angle with the central body 30) relative to the first opening (semicylindrical channel 326 in Fig. 19).
Regarding claim 6, modified Spitler discloses the stabilization device (securement device 300) of claim 1, wherein the bottom surface (lower surface 314 in Fig. 20) of the base (anchor pad 310) comprises an adhesive configured to releasably attach the base (anchor pad 310) to skin (skin 10 in Fig. 1) of a patient onto which the stabilization device (securement system 300) is applied.
Regarding claim 7, modified Spitler discloses the stabilization device (securement system 300) of claim 1, wherein the support surface (retainer 320) is angled relative to the base (anchor pad 310) such that the catheter adapter (medical article 20) received within the support surface perimeter (boundary of retainer 320) is not parallel to the skin (skin 10) of a patient (Fig. 17, Col 43-55, preferably 7-15 degrees relative to the skin of the patient) onto which the stabilization device (securement system 300) is applied.
Regarding claim 8, modified Spitler discloses the stabilization device (securement system 300) of claim 7, wherein the support surface (retainer 320) comprises a foam (Bierman, Col 7, Lines 11-13).
Regarding claim 9, modified Spitler discloses the stabilization device (securement system 300) of claim 7, wherein the support surface (retainer 320) is angled from about 3 degrees to about 10 degrees relative to the skin (skin 10) of the patient (Fig. 17, Col 43-55, preferably 7-15 degrees relative to the skin of the patient) onto which the stabilization device (securement system 300) is applied.
Regarding claim 10, modified Spitler discloses the stabilization device (securement system 300) of claim 1 wherein the dressing is substantially transparent (Bierman, Figs. 9-10 (114) Col 6, Lines 35-40).
Regarding claim 11, modified Spitler discloses the stabilization device (securement system 300) of claim 1 with a base (anchor pad 310), but modified Spitler fails to disclose a cutout configured to receive the catheter therein.
Bierman teaches a stabilization device (securement device 55 in Fig. 2) that comprises a base (anchor pad 60 in Fig. 2) and a cutout (front edge 62 with a cavity 66 in Fig. 2) configured to engage the patient’s skin (Col 4, Lines 1-6).
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 anchor pad of Spitler to include a cutout as taught by Bierman in order to accommodate a catheter and to accommodate additional adhesives or antimicrobial compositions at the site of insertion.
Regarding claim 12, modified Spitler discloses the stabilization device (securement system 300) of claim 11, wherein the base (anchor pad 310) comprises one or more alignment markers (Albany: markers 1527 in Fig. 15C; para [0178]).
Regarding claim 13, modified Spitler discloses the stabilization device (securement system 300) of claim 11, wherein the base (anchor pad 310) comprises two alignment markers (Albany: markers 1527 in Fig. 15C; para [0178]) arranged on opposite sides of the cutout (Albany: the hub component 1207 has four markers 1527, two of which are disposed proximate to a first side of the opening 1525 and two of which are disposed proximate to a second side of the opening 1525; para [0178]).
.
Regarding claim 16, Spitler discloses the stabilization device (securement system 300) of claim 1, wherein the base (anchor pad 310) comprises one or more second support surfaces (top side of anchor pad 310 onto which retainer 320 is secured and by which retainer 320 is supported, Col 13, Lines 41-48).
Regarding claim 17, Spitler discloses the stabilization device (securement system 300) of claim 16, wherein the one or more second support surfaces (top side of anchor pad 310) are positioned outside of the base perimeter (area of anchor pad 310 that extends beyond support surface of perimeter of retainer 320, Col 13, Lines 48-53).
Claim15 is rejected under 35 U.S.C. 103 as being unpatentable over Spitler in view of Bierman and in view of Albany, as applied to claim 1 above, in further view of Blake (US Publication No 2021/0205144), hereinafter, Blake.
Regarding claim 15, modified Spitler discloses the stabilization device (securement system 300) of claim 1 and a base (anchor pad 310), but fails to disclose a base that comprises one or more first positioning markers and a top dressing that comprises one or more corresponding positioning markers, such that when the top dressing is applied, the one or more corresponding positioning markers overlay the one or more first positioning markers.
Blake teaches a base (primary dressing 12 in Fig. 2) that comprises one or more first positioning markers (base markings 30 in Fig. 2) and a top dressing (cover dressing 18 in Fig. 2) that comprises one or more corresponding positioning markers (alignment markers 36 Fig. 2), such that when the top dressing (cover dressing 18) is applied, one or more corresponding positioning markers (alignment markers 36) overlay the one or more first positioning markers (base markings 30, para [0044]).
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 base and top dressings of modified Spitler to add first positioning markers to the base and corresponding positioning markers to the top dressing as taught by Blake in order to provide for visible confirmation of proper alignment of base and top dressings.
Claim 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Spitler in view of Bierman and in view of Albany, as applied to claim 1 above, and further in view of Blanchard (US Publication No 2022/0313973), hereinafter, Blanchard.
Regarding claim 18, modified Spitler discloses all limitations in claim 18 as applied to claim 1, but fails to disclose a stabilized catheter set, comprising: a catheter assembly comprising: a catheter adapter, comprising: a distal end; a proximal end; a lumen arranged between and in fluid communication with the distal end and the proximal end; and a catheter arranged at the distal end of the catheter adapter and in fluid communication with the lumen.
Blanchard teaches a stabilized catheter set, comprising: a catheter assembly (catheter assembly 52 in Fig. 3A) comprising: a catheter adapter (catheter adapter 54 in Fig. 3A), comprising: a distal end (distal end 56 in Fig. 3A); a proximal end (proximal end 58 in Fig. 3A); a lumen (lumen 60 in Fig. 3A) arranged between and in fluid communication with the distal end and the proximal end (para [0081], Lines 4-5); and a catheter (catheter 62 in Fig. 3A) arranged at the distal end (distal end 56) of the catheter adapter (catheter adapter 54, para [0081], Lines 5-7) and in fluid communication with the lumen (lumen 60, para [0072], Lines 6-8).
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 stabilization device of modified Spitler to be able to stabilize the catheter set taught by Blanchard in order to properly secure catheter assemblies on patient skin.
.
Regarding claim 19, modified Spitler discloses the stabilized catheter set (catheter assembly 52 in Fig. 3A) of claim 18, but fails to disclose a catheter adapter further comprising a port in fluid communication with the lumen.
Blanchard teaches a catheter adapter (catheter adapter 12 in Fig. 1B) comprising a port (side port 18 in Fig. 1B) in fluid communication (para[0072, Lines 4-8]) with the lumen (lumen 20 in Fig. 1B).
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 set in modified Spitler to include a port in fluid communication with the lumen as taught by Blanchard in order to provide additional access for infusion or withdrawal of fluids through the same catheter lumen.
Regarding claim 20, modified Spitler discloses the stabilized catheter set (catheter assembly 52 in Fig. 3A) of claim 19, but fails to disclose a fluid conduit having a distal end and a proximal end, the distal end coupled to and in fluid communication with the port.
Blanchard teaches a fluid conduit (extension tube 24 in Fig. 1B) having a distal end and a proximal end, the distal end coupled to and in fluid communication with the port (side port 18 in Fig. 1B, para [0073], Lines 7-9).
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 set of modified Spitler to further include a fluid conduit coupled to the adapter port as taught by Blanchard in order to deliver or withdraw fluids through the side port while the catheter remains secured.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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