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 February 2nd 2026 has been entered. Claims 1-11 and 13-27 are pending in the application. Applicant’s amendments to the Specification and Claims have overcome the Specification objection and the Claim objections previously set forth in the Non-Final Office Action mailed September 2nd 2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the plurality of protrusions are embedded in and are completely surrounded by the body contact portion such that the body contact portion forms a corresponding plurality of protrusions”, subject matter of amended claim 1, and “…wherein the body contact portion abuts the flange“, subject matter of claims 22 and 26, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The Examiner notes that one protrusion 66 is depicted, not a plurality.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5-7, 9, 11, and 13-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding amended claim 1, the new limitation of “such that the body contact portion forms a corresponding plurality of protrusions” is not supported by the original disclosure and is considered new matter. The specification and drawings provide no detail of a “corresponding plurality of protrusions” formed by the body contact portion.
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.
Claim(s) 1-3, 5-6, 11, 13-20, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20170119997 A1), in view of Brimhall (US 20020177816 A1).
Regarding claim 1, Burkholz discloses a catheter adapter (catheter adapter 18, [0040] & Fig. 1) comprising: a housing having a proximal end and a distal end (body 48 extending from proximal end 22 to distal end 20, [0049] & Fig. 1); and
an extension portion extending from the distal end of the housing (adapter tip 32 and distal tip region 94 extending from the distal end of body 48, [0041] & Fig. 2), the extension portion having a proximal end and a distal end and defining a passageway configured to receive a catheter (region 94 having a proximal and distal end and defining a passageway configured to receive catheter 12, [0041]-[0042] & Fig. 1-2),
wherein the housing comprises a first material and the extension portion comprises a second material (adapter 18, including body 48, made of a first material and adapter tip 32, including region 94, made from a second material, [0040] & Fig. 1-2), and the second material is more flexible than the first material (“at least a portion of the catheter adapter 18 is made from a first material and at least a portion of the adapter tip 32 is made from a second material that is more flexible than the first material.”, [0040]); wherein the housing comprises:
a body having a proximal end and a distal end (the length of body 48 extending from proximal end 92 of extension 88 to access port 54 is being interpreted as the housing, [0041] & Fig. 1-2); an access port extending from the body (lateral access port 56 extending from body 48, [0050] & Fig. 1); and wherein a body contact portion covers at least a portion of the housing (wing element 62 covering a portion of housing 48, [0052] & see Fig. 1-4).
However, Burkholz fails to explicitly disclose a plurality of protrusions extending from the body and/or the access port, wherein the plurality of protrusions are embedded in and are completely surrounded by the body contact portion such that the body contact portion forms a corresponding plurality of protrusions.
However, Brimhall teaches a catheter adapter (catheter adapter 24, Fig. 1-6) comprising a plurality of protrusions extending from the body (stiffening members 27 extending from catheter adapter 24, [0031] and [0035] & Fig. 1-6), wherein the plurality of protrusions are embedded in and are completely surrounded by the body contact portion such that the body contact portion forms a corresponding plurality of protrusions (stiffening members 27 are embedded in wings 26 as wings 26 are molded over members 27, [0031] and [0035] & Fig. 1-2 and 6; wings 26, which are being interpreted as a body contact portion as the wings are intended to contact the body, form two wings which are being interpreted as a corresponding plurality of protrusions, [0031]-[0032] & Fig. 5).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter adapter of Burkholz with Brimhall to include a plurality of protrusions extending from the body, wherein the plurality of protrusions are embedded in and are completely surrounded by the body contact portion such that the body contact portion forms a corresponding plurality of protrusions, since such a modification would “provides rigidity to the wing to allow the clinician to precisely control the position and movement of the catheter” and allows the clinician to shape the wings to more closely match the contour of the patient's skin and thus enhance patient comfort ([0013] and [0033] of Brimhall).
As modified, stiffening members 27 of Brimhall would extend from body 48 of catheter adapter 18 of Burkholz, with first and second wing members 68 and 70 of wing element 62 of Burkholz, synonymous to wings 26 of Brimhall, being the corresponding plurality of protrusion of wing element 62.
Regarding claim 2, Burkholz, as modified, discloses all the limitations of claim 1. Burkholz further discloses the catheter adapter wherein the first material is a polymer and the second material is an elastomer (see [0040]).
Regarding claim 3, Burkholz, as modified, discloses all the limitations of claim 1. Burkholz further discloses the catheter adapter wherein the second material has a hardness of 50-70 shore A (“the second material has a durometer value in the range of 30 Shore A to 90 Shore D, with a preferred range of −50 to 90 Shore A. Durometer hardness may be determined under test method ASTM D2240”, see [0040]).
Regarding claim 5, Burkholz, as modified, discloses all the limitations of claim 1. Burkholz further discloses the catheter adapter wherein an outer diameter of the extension portion is the same as an outer diameter of the distal end of the housing (as seen in Figures 1-3, the outer diameter of distal region 94 is the same as the outer diameter of the distal end of body 48).
Regarding claim 6, Burkholz, as modified, discloses all the limitations of claim 1. However, the embodiment of Figures 1-7 of Burkholz fails to explicitly disclose the catheter adapter wherein an outer diameter of the extension portion is less than an outer diameter of the distal end of the housing. However, the embodiment of Figures 8-10 teaches the catheter adapter wherein an outer diameter of the extension portion is less than an outer diameter of the distal end of the housing (as seen in Figures 8-10, the outer diameter of adapter tip 132 is less than the outer diameter of the distal end of the body of adapter 118).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the outer diameter of the extension portion to be less than an outer diameter of the distal end of the housing since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Regarding claim 11, Burkholz, as modified, discloses all the limitations of claim 1. Burkholz further discloses the catheter adapter further comprising the body contact portion (wing element 62 is being interpreted as the body contact portion, see [0051]-[0053] & Fig. 2-4 and annotated Figure 2 below, the body contact portion annotated as “Body Contact Portion”) comprising an upper surface corresponding to a surface of the housing and a lower surface defining an outer surface of the catheter adapter (annotated Figure 2 below annotating the upper surface as “Upper Surface” which corresponds to a surface of body 48 and lower surface annotated as “Lower Surface” defining an outer surface of adapter 18, see below).
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Regarding claim 13, Burkholz, as modified, discloses all the limitations of claim 1. Burkholz further discloses the catheter adapter wherein an extension tip extends from the distal end of the body of the housing (extension 88 and the distalmost segment of body 48 are both being interpreted as the extension tip, [0041] & Fig. 1-2 and 4; annotated Figure 1 below denoting the distalmost segment of body 48 as “Extension Tip”), and the extension portion surrounds at least a portion of the extension tip (tip 32 surrounding extension 88, [0041] & Fig. 2).
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Regarding claim 14, Burkholz, as modified, discloses all the limitations of claim 13. Burkholz further discloses the catheter adapter wherein the extension tip comprises a central portion defining a lumen (extension 88 having a lumen through its center, see Fig. 2) and a flange that surrounds the central portion (the flange surrounds the central portion of extension 88, see Fig. 1-4; annotated Figure 1 above denoting the flange as “Flange”), the central portion extending distally beyond the flange (extension 88 extends distally beyond the flange, see Figs. 1-4).
Regarding claim 15, Burkholz, as modified, discloses all the limitations of claim 13. Burkholz further discloses the catheter adapter wherein a notch is provided in the extension tip (the opening in which connecting channel 66 is partially formed is being interpreted as the notch, see [0053] & Fig. 2-3; see annotated Figure 2 above denoting the notch as “Notch”; this opening would inherently be formed in the structure being interpreted as the extension tip, see annotated Figures 1 and 2 above).
Regarding claim 16, Burkholz, as modified, discloses all the limitations of claim 13. Burkholz further discloses the catheter adapter further comprising a connection portion connecting the extension portion to the body contact portion (connecting channel 66 connecting adapter tip 32 to wing element 62, [0053] & Fig. 2), wherein the connection portion extends through and substantially fills the notch in the extension tip of the housing (channel 66 extending through and substantially filling the notch, [0053] & Fig. 2 and annotated Figures 1 and 2 above).
Regarding claim 17, Burkholz, as modified, discloses all the limitations of claim 13. Burkholz further discloses the catheter adapter further comprising a recess in an outer surface of the body of the housing in an area covered by the body contact portion (the bottom surface of body 48 covered by wing element 62 is being interpreted as the recess, see Fig. 2-4).
Regarding claim 18, Burkholz, as modified, discloses all the limitations of claim 17. Burkholz further discloses the catheter adapter wherein an extension tip extends from the distal end of the body of the housing (the extension tip extending from the distal end of body 48, [0041] & see annotated Figure 1 above), a notch is provided in the extension tip (the opening in which connecting channel 66 is partially formed is being interpreted as the notch, see [0053] & Fig. 2; see annotated Figure 2 above denoting the notch as “Notch”; this opening would inherently be formed in the structure being interpreted as the extension tip, see annotated Figures 1 and 2 above), and the recess is connected to the notch in the extension tip (the bottom surface of housing 48 covered by wing element 62 connected to the opening in which connecting channel 66 is formed, the notch, see Fig. 2-4 and annotated Figures 1 and 2), such that a sidewall of the notch is continuous with a sidewall of the recess (a sidewall of the notch is continuous with a sidewall of the recess, see annotated Figure 2A below; the sidewall of the notch annotated as “Notch Sidewall” and the sidewall of the recess annotated as “Recess Sidewall”; the two walls sharing a connection point).
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Regarding claim 19, Burkholz, as modified, discloses all the limitations of claim 18. Burkholz further discloses the catheter adapter wherein the recess extends around an outer circumference of the body of the housing for an angular distance (as seen in Figure 3 and 4, the bottom surface of body 48 covered by wing element 62 extends around an outer circumference of body 48 for an angular distance), an angular distance defined by the notch in the extension tip (the notch in the extension tip having an angular distance as seen in Figure 3), and a circumferential width of a distal end of the recess is less than a circumferential width of the proximal end of the recess (the circumferential width of a distal end of the bottom surface of body 48 covered by wing element 62 is less than a circumferential width of a proximal end of the bottom surface of body 48 covered by wing element 62, see Fig. 4).
However, Burkholz fails to explicitly disclose the catheter adapter wherein the recess extends around an outer circumference of the body of the housing for an angular distance equal to an angular distance defined by the notch in the extension tip.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the catheter adapter of Burkholz, as modified, to have the recess extend around an outer circumference of the body of the housing for an angular distance equal to an angular distance defined by the notch in the extension tip since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the catheter adapter of Burkholz would not operate differently with the claimed angular distances. The notch and recess would still be connected along a sidewall and connecting channel 66 would still be formed between tip 32 and element 62 rendering the catheter adapter operable. Further, applicant places no criticality on the claimed distances, indicating simply that “the recess 54 may extend around the outer circumference of the body 20 of the housing 16 for an angular distance equal to the angular distance defined by the notch 50 in the extension tip 24…” (specification pp. [0072]).
Regarding claim 20, Burkholz, as modified, discloses all the limitations of claim 17. Burkholz further discloses catheter adapter wherein the recess extends along a length of the body of the housing from a notch in the extension tip to a location proximal to the access port (the opening in which connecting channel 66 is partially formed is being interpreted as the notch, see [0053] & Fig. 2; see annotated Figure 2 above denoting the notch as “Notch”; this opening would inherently be formed in the structure being interpreted as the extension tip, see annotated Figures 1 and 2 above; the recess extends along a length of body 48 from the notch to a location proximal to port 56, see Figs. 2 and 4).
Regarding claim 25, Burkholz, as modified, discloses all the limitations of claim 1. Burkholz, as modified, further discloses the catheter adapter wherein the protrusions have a flat, wing-shaped configuration (stiffening members 27 of Brimhall, as modified onto catheter adapter 18 of Burkholz, have a flat, wing shaped configuration, see Fig. 1-6 of Brimhall).
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20170119997 A1), and further in view of Bourne (EP 0616817 A1).
Regarding claims 7 and 9, Burkholz, as modified, discloses all the limitations of claim 1. Burkholz further discloses the catheter adapter wherein the extension portion comprises a top portion and a bottom portion positioned opposite the top portion, the bottom portion configured to face a skin surface of a patient (distal end of adapter tip 32 is being interpreted as the top portion and proximal end of adapter tip 32 – defined at the proximal end of region 94 – is being interpreted as the bottom portion, [0041] & Fig. 1-2; the bottom portion capable of facing a skin surface of a patient).
However, Burkholz fails to explicitly disclose the catheter adapter wherein the extension portion comprises a plurality of radial channels, wherein the plurality of radial channels are only provided on the bottom portion of the extension portion.
However, Bourne teaches a catheter adapter (manifold 20, abstract & Fig. 1-2) wherein the extension portion comprises a plurality of radial channels (strain relief 40 comprising concentric ribs 44 extending around the distal end 45, Col 8 lines 34-40 & Fig. 2), wherein the plurality of radial channels are only provided on the bottom portion of the extension portion (concentric ribs 44 seen not extending through the distal end of strain relief 40, see Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter adapter of Burkholz, as modified, with Bourne to include the extension portion comprising a plurality of radial channels, wherein the plurality of radial channels are only provided on the bottom portion of the extension portion, since such a modification would enhance the flexibility of the distal portion of the strain relief and yield predictable results pertaining to strain relief bendability (see Col 8 lines 34-56 of Bourne).
Claim(s) 21-23 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20170119997 A1), in view of Brimhall (US 20020177816 A1), and further in view of Burkholz (US 20180318557 A1).
Regarding claim 21, Burkholz, as modified, discloses all the limitations of claim 17. However, Burkholz fails to explicitly disclose the catheter adapter wherein at least one secondary protrusion extending from the outer surface of the body of the housing is provided in the recess.
However, Burkholz ‘557 teaches a catheter adapter (catheter adapter 18, [0087] & Fig. 1A) wherein at least one secondary protrusion extending from the outer surface of the body of the housing is provided in the recess (adapter 18 made of two materials, a second material illustrated with a stippled shading, [0137]-[0139] & Fig. 12A-12J; “the first material may extend into the second material to provide shape and/or support... In some embodiments, the first material may extend beyond surfaces of the second material in order to improve product functionality. In these and other embodiments, the first material may act as one or more interface friction reducers 82, as illustrated, for example, in FIG. 12J. In some embodiments, the friction reducers 82 may decrease friction between the catheter system 10 and the skin of the patient and/or the wing 22. In some embodiments, one or more of the interface friction reducers 82 may include a protrusion.”, [0153] & Fig. 12I-12J; friction reducers 82 being protrusions extending from a bottom surface of catheter adapter 18 and made of the same, first material of adapter 18).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter adapter of Burkholz, as modified, with Burkholz ‘557 to include at least one secondary protrusion extending from the outer surface of the body of the housing and provided in the recess since such a modification would include structure to help provide shape and/or support to the catheter and decrease friction between the catheter and the skin of the patient (see [0153] of Burkholz ‘557).
Regarding claim 22, Burkholz, as modified, discloses all the limitations of claim 13. However, Burkholz fails to explicitly disclose the catheter adapter further comprising a flange extending laterally from an outer surface of the body of the housing, wherein the body contact portion abuts the flange.
However, Burkholz ‘557 teaches a catheter adapter (catheter adapter 18, [0087] & Fig. 1A) further comprising a flange extending laterally from an outer surface of the body of the housing (flexible central push tab feature 28 extending laterally from an outer surface of the adapter 18 housing, [0090] and [0146] & Fig. 1C and 12A), wherein the body contact portion abuts the flange (tab feature 28 and flexible securement platform 26 are connected and formed of the same material, [0090] and [0146] & Fig. 12A, 12H, 12K).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter adapter of Burkholz, as modified, with Burkholz ‘557 to include a flange extending laterally from an outer surface of the body of the housing, wherein the body contact portion abuts the flange, since such a modification would improve mold filling and user grip compatibility and yield predictable results pertaining to improved user grip on the device (see [0090] and [0146] of Burkholz ‘556). As modified, push tab feature 28 would be included on the catheter adapter of Burkholz - feature 28 of Burkholz ‘557 extending from body 48 and in contact with wing element 62 of Burkholz.
Regarding claim 23, Burkholz, as modified, discloses all the limitations of claim 22. Burkholz, as modified, further discloses the catheter adapter further comprising a recess in an outer surface of the body of the housing in an area covered by the body contact portion (the bottom surface of body 48 covered by wing element 62 is being interpreted as the recess, see Fig. 2-4),
wherein the plurality of protrusions extending from the body of the housing are positioned between the flange of the housing and the recess and are circumferentially spaced from the recess (as modified, stiffening members 27 of Brimhall would be positioned between push tab feature 28 of Burkholz ‘557 and the bottom surface of body 48; members 27 of Brimhall circumferentially spaced from the bottom surface of body 48, see Figs. 1 and 3-4 of Burkholz and Fig. 2-6 of Brimhall).
Regarding claim 26, Burkholz, as modified, discloses all the limitations of claim 1. However, Burkholz fails to explicitly disclose the catheter adapter further comprising a flange extending laterally from an outer surface of the body of the housing, wherein the body contact portion abuts the flange, and a lateral distance that the protrusions extend from the housing is greater than a lateral distance that the flange extends from the housing.
However, Burkholz ‘557 teaches a catheter adapter (catheter adapter 18, [0087] & Fig. 1A) further comprising a flange extending laterally from an outer surface of the body of the housing (flexible central push tab feature 28 extending laterally from an outer surface of the adapter 18 housing, [0090] and [0146] & Fig. 1C and 12A), wherein the body contact portion abuts the flange (tab feature 28 and flexible securement platform 26 are connected and formed of the same material, [0090] and [0146] & Fig. 12A, 12H, 12K), and
a lateral distance that the plurality of protrusions extend from the housing is greater than a lateral distance that the flange extends from the housing (two wing shaped features, made of the first material, extending from the left and right of adapter 18 intended to provide shape and support, are being interpreted as a plurality of protrusions extending from adapter 18, see [0153] & Fig. 12I; securement platform 26 may also include one or more wings 33 extending from adapter 18, which may alternatively be interpreted as a plurality of protrusions, see [0161] & Fig. 15A and 15D; the two wing shaped features (Fig. 12I) and/or wings 33 laterally extend further from the housing of adapter 18 than the lateral extension of feature 28 from the housing of adapter 18, see all of Figs. 12 and Figs. 14-15 and 15D).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter adapter of Burkholz, as modified, with Burkholz ‘557 to include a flange extending laterally from an outer surface of the body of the housing, wherein the body contact portion abuts the flange, and a lateral distance that the protrusions extend from the housing is greater than a lateral distance that the flange extends from the housing, since such a modification would improve mold filling and user grip compatibility and yield predictable results pertaining to improved user grip on the device (see [0090] and [0146] of Burkholz ‘556).
As modified, push tab feature 28 would be included on the catheter adapter of Burkholz - feature 28 of Burkholz ‘557 extending from body 48 and in contact with wing element 62 of Burkholz. Stiffening members 27 of Brimhall, as modified onto adapter 18, would extend at a greater lateral distance than feature 28.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20170119997 A1), in view of Brimhall (US 20020177816 A1), and further in view of Breindel (US 20200094016 A1).
Regarding claim 24, Burkholz, as modified, discloses all the limitations of claim 1. Burkholz, as modified, further discloses the catheter adapter wherein at least one of the plurality of protrusions extends from the body of the housing (as modified, stiffening members 27 extend from body 48 of adapter 18, see [0035] & Fig. 1-6 of Brimhall).
However, Burkholz fails to explicitly disclose at least one of the plurality of protrusions extends from the access port. However, Breindel teaches a catheter adapter (catheter hub 200, [0025] & Fig. 2-4) including one or more ledges 220 that are configured to provide structural reinforcement as support for a wing assembly (see [0028] and [0032] of Breindel), synonymous to stiffening members 27 providing rigidity to wings 26 of Brimhall (see [0013] and [0033] of Brimhall).
Breindel teaches a catheter adapter wherein at least one of the plurality of protrusions extends from the body of the housing and at least one of the plurality of protrusions extends from the access port (one or more ledges 220 extending from catheter hub 200 and side port 210, [0026] and [0028] & Fig. 1-4).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the plurality of protrusions of Burkholz, as modified, with Breindel to include at least one of the plurality of protrusions extending from the access port as Breindel teaches this to be an art effective placement for structural reinforcements, extending from a catheter adapter, configured to reinforce a wing assembly while allowing the wing assembly to maintain its flexibility ([0028] and [0032] of Breindel), like stiffening members 27 of Brimhall modified onto adapter 18 to provide rigidity to wing element 62 of Burkholz.
Response to Arguments
Applicant's arguments filed February 2nd 2026 have been fully considered but they are not persuasive. In response to Applicant’s arguments directed toward the drawing objections, the Examiner finds that drawings do not “express illustration” of the combined features as claimed, such as “the plurality of protrusions are embedded in and are completely surrounded by the body contact portion such that the body contact portion forms a corresponding plurality of protrusions” and “wherein the body contact portion abuts the flange”. The Examiner believes drawings of these features, and how they interact with their corresponding features as claimed, is necessary for an understating of the claimed subject matter to be patented.
Applicant’s arguments, see page 8 last paragraph-page 9 last paragraph, filed February 2nd 2026, with respect to the 112(b) rejection of claims 12-26 have been fully considered and are persuasive. The 112(b) rejection of claims 12-26 has been withdrawn.
Applicant’s arguments with respect to the prior art rejections of the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Abitabilo (US 20170239443 A1).
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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