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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6 April 2026 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 6 April 2026 wherein Claims 1, 4, 7, 14, 18, 20, 21, and 22 are amended, Claims 23 – 25 are newly added, and Claims 3, 8, and 15 – 17 are or previously were cancelled. Therefore, Claims 1, 2, 4 – 7, 9 – 14, 18 – 25 are currently pending.
The Applicant’s amendment to the Claims dated 6 April 2026 has overcome each Claim Objection set forth in the Final Rejection dated 6 January 2026 (hereinafter referred to as the “Final Rejection”). Therefore, each Claim Objection set forth in the Final Rejection are withdrawn.
The Applicant’s amendments to the Claims dated 6 April 2026 has overcome each Claim Rejection set forth under 35 U.S.C. §§ 112(a) and 112(b). Therefore, each Claim Rejection set forth under 35 U.S.C. §§ 112(a) and 112(b) are withdrawn.
Response to Arguments
Applicant’s arguments, see pages 9 – 12, filed 6 April 2026, with respect to the rejection(s) of independent claim(s) 1 and 14 and their respective dependent claims under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the following:
Funk et al. (US 2018/0344983 A1), Lampropoulos (US 2006/0142699 A1), and Abitabilo et al. (US 2017/0239443 A1); and
Funk et al. (US 2018/0344983 A1), Lampropoulos (US 2006/0142699 A1), and Goral et al. (US 2016/0220805 A1).
Applicant's arguments, see pages 12 – 14 with respect to independent claim 20, filed 6 April 2026 have been fully considered but they are not persuasive.
The Applicant alleges that Funk et al. (US 2018/0344983 A1) nor Lampropoulos (US 2006/0142699 A1) discloses, teaches, or suggests “[the] fixation element includ[es] a pair of wings and at least one connection mechanism,” “the first wing and/or the second wing includes a free end portion projecting axially beyond the at least one connection mechanism and disposed radially spaced apart from the catheter hub base part,” and “a gap is defined by and radially between the free end portion and the catheter hub base part.” See pages 12 – 13 of the Applicant’s arguments. The Examiner respectfully disagrees.
Funk discloses a fixation element (200) including a pair of wings (see at the left 216 and right 216 in Figure 5) and at least one connection mechanism (see Examiner annotated Fig. 3 below; hereinafter referred to as “Fig. B”), the pair of wings including a first wing (see right 216 in Fig. 6, [0055], and [0057]) and a second wing (see left 216 in Fig. 6, [0055] and [0057]) that are each connected to and project from the at least one connection mechanism (see Fig. B below); and
a coupling element (263) (see [0056]) connected to the catheter hub rotatable part (see [0056]);
wherein the fixation element is connected to the catheter hub via the at least one connection mechanism and further includes at least one recess (see left 216 and right 216 in Fig. 5) that is configured to engage the coupling element (see Fig. 7);
wherein the first wing and/or the second wing includes a free end portion (see Examiner annotated Fig. 6 below; hereinafter referred to as “Fig. C”) projecting axially beyond the at least one connection mechanism and disposed radially spaced apart from the catheter hub (see Fig. C and Fig. 7); and
wherein a gap (see Examiner annotated Fig. 7 below; hereinafter referred to as “Fig. D”) is defined by and radially between the free end portion and the catheter hub (see Fig. D below). Here the gap is the annotated distal portion of the stabilization device 200 that separates the annotated free end portion from the catheter hub.
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Funk discloses, teaches, and suggests “the first wing and/or the second wing includes a free end portion projecting axially beyond the at least one connection mechanism and disposed radially spaced apart from the catheter hub,” and “a gap defined by and radially between the free end portion and the catheter hub.” Therefore, the Applicant’s argument is unpersuasive.
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 “wherein the first wing and/or the second wing includes a free end portion projecting axially beyond the at least one connection mechanism and disposed radially spaced apart from the catheter hub; and wherein a gap is defined by and radially between the free end portion and the catheter hub” (as recited in Claims 20, 25) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 – 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because the recitation of “wherein a gap is defined by and radially between the free end portion and the catheter hub” is unclear. Claim 20 recites “wherein the first wing and/or the second wing includes a free end portion projecting axially beyond the at least one connection mechanism and disposed radially spaced apart from the catheter hub; and wherein a gap is defined by and radially between the free end portion and the catheter hub.” Does “a gap is defined by and radially between the free end portion and the catheter hub” refer to the free end portion of the first wing, the free end portion of the second wing, or the free end portions of both the first wing and the second wing? The alternative language of “and/or” in the preceding claim limitation creates indefiniteness later on within the claim.
Claims 21 – 23 are dependent upon Claim 20 and are therefore rejected under 35 U.S.C. § 112(b) for the same rationale.
Claim 24 recites “the catheter hub base portion.” This claim limitation lacks antecedent basis within the claims. Claim 1, upon which Claim 24 depends, previously recites “the catheter hub base part.” Is the “catheter hub base portion” supposed to be the “catheter hub base part” in Claim 24?
Claim 25 recites “the first wing and/or the second wing.” These claim limitations lack antecedent basis within the claims. Claim 1, upon which Claim 25 depends, previously recites “a right wing and a left wing.” Is the “first wing and second wing” supposed to be the “right and left wing?”
Claim 25 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because the recitation of “wherein a gap is defined by and radially between the free end portion and the catheter hub” is unclear. Claim 25 recites “the first wing and/or the second wing includes a free end portion projecting axially beyond the annular body and disposed radially spaced apart from the catheter hub; and wherein a gap is defined by and radially between the free end portion and the catheter hub.” Does “a gap is defined by and radially between the free end portion and the catheter hub” refer to the free end portion of the first wing, the free end portion of the second wing, or the free end portions of both the first wing and the second wing? The alternative language of “and/or” in the preceding claim limitation creates indefiniteness later on within the claim.
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(s) 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Funk et al. (US 2018/0344983 A1) (hereinafter referred to as “Funk”) and Lampropoulos (US 2006/0142699 A1).
With regard to claim 20, Funk discloses (see Figs. 3 – 9) a catheter assembly (see Fig. 7), comprising:
a catheter hub (260) (see [0045]) having a longitudinal axis A (A) (see [0056] and Fig. 7), the catheter hub including a base portion (262) (see [0055]) and a rotatable part (see at 260 in Fig. 7) that is operable to rotate about the axis A (see [0057]);
a fixation element (200) including a pair of wings (see at the left 216 and right 216 in Figure 5) and at least one connection mechanism (see Examiner annotated Fig. 3 below; hereinafter referred to as “Fig. B”), the pair of wings including a first wing (see right 216 in Fig. 6, [0055], and [0057]) and a second wing (see left 216 in Fig. 6, [0055] and [0057]) that are each connected to and project from the at least one connection mechanism (see Fig. B below); and
a coupling element (263) (see [0056]) connected to the catheter hub rotatable part (see [0056]);
wherein the fixation element is connected to the catheter hub via the at least one connection mechanism and further includes at least one recess (see left 216 and right 216 in Fig. 5) that is configured to engage the coupling element (see Fig. 7);
wherein the first wing and/or the second wing includes a free end portion (see Examiner annotated Fig. 6 below; hereinafter referred to as “Fig. C”) projecting axially beyond the at least one connection mechanism and disposed radially spaced apart from the catheter hub (see Fig. C and Fig. 7); and
wherein a gap (see Examiner annotated Fig. 7 below; hereinafter referred to as “Fig. D”) is defined by and radially between the free end portion and the catheter hub (see Fig. D below).
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However, Funk is silent with regards to:
wherein the catheter hub rotatable part is rotatable about the axis A in relation to the fixation element and in relation to the catheter hub base portion.
Nonetheless Lampropoulos, which is within the analogous art of introducer sheaths with rotational components (see abstract), teaches (see Figs. 1A – 1B) wherein the catheter hub rotatable part (112, 150) (see [0027] “side port 112 is attached to head portion 150 and suture ring 145 is attached to base portion 160…This can allow the user to rotate either one or both of suture ring 145 and side port 112 relative to one another”) is rotatable about the axis A in relation to the fixation element (145) and in relation to the catheter hub base part (160) (see Fig. 1B and [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter hub rotatable part and the catheter hub base part of the catheter assembly of Funk in view of a teaching of Lampropoulos such that wherein the catheter hub rotatable part is rotatable about the axis A in relation to the fixation element and in relation to the catheter hub base part. One of ordinary skill in the art would have been motivated to make this modification because Lampropoulos teaches that this configuration allows for easy manipulation of components of the catheter assembly to accommodate both left and right-handed users. Lampropoulos also teaches that the configuration can be adapted to various spatial constraints with minimal efforts. See [0011] of Lampropoulos.
Here, modifying the catheter hub rotatable part and catheter hub base part of the catheter assembly of Funk in view of Lampropoulos would be beneficial because it would allow for the selection between a left handed or right handed configuration of the side channels 216, side port 263 and flexible tubing 265 while retaining the catheter hub base part, the distal locking mechanism 262, within the coupling surface 212 of the fixation element 200. Without the rotational configuration taught by Lampropoulos the distal locking mechanism would rotate as well thereby potentially becoming dislodged from the fixation element. Therefore, a person of ordinary skill would recognize the need and benefit to have the catheter hub rotatable part rotate while the catheter hub base part remains fixed.
The catheter assembly of Funk modified in view of a teaching of Lampropoulos will hereinafter be referred to as the catheter assembly of Funk and Lampropoulos.
With regard to claim 21, the catheter assembly of Funk and Lampropoulos teaches the claimed invention of claim 20, and Funk further teaches at least one connection mechanism (see Fig. B above) includes a first connection mechanism (see the left annotated connection mechanism in Fig. B above) and a second connection mechanism (see the right annotated connection mechanism in Fig. B) coupling the fixation element (200) to the catheter hub base portion (262) (see Fig. 7); and the catheter hub rotatable part (see at 260 in Fig. 7) and the coupling element (263) are disposed between the first connection mechanism and the second connection mechanism (see Fig. 7).
Claim(s) 1, 2, 5, 6, 9, 10, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Funk, Lampropoulos, and Abitabilo et al. (US 2017/0239443 A1) (hereinafter referred to as “Abitabilo”).
With regard to claim 1, Funk discloses (Figs. 3 – 9) a catheter assembly (see Fig. 7) extending along a longitudinal axis A (A) (see [0056] and Fig. 7), the catheter assembly comprising:
a catheter hub (260) (see [0045]) comprising a base part (262) (see [0055]), a catheter hub rotatable part (see at 260 in Fig. 7), and a coupling element (263) (see [0056]) connected to the catheter hub rotatable part; and
a fixation element (200) (see [0043]) connected to the catheter hub (see Fig. 7), the fixation element including a pair of wings having a right wing (see at the left 216 in Fig. 5) and a left wing (see at the right 216 in Fig. 5);
wherein the right wing includes a right wing recess (see right 216 in Fig. 5, [0055] and [0057]) and the left wing includes a left wing recess (see left 216 in Fig. 5, [0055], and [0057]), the right wing recess and the left wing recess each configured to receive the coupling element such that the coupling element fits within the right wing recess or the left wing recess (see [0056] and [0057]);
wherein the fixation element further includes at least one coupling mechanism (see Examiner annotated Fig. 3 below hereinafter referred to as “Fig. A”) formed integrally with the fixation element and coupling the fixation element to the catheter hub (see Fig. 7).
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However, Funk is silent with regards to the following:
wherein the catheter hub rotatable part is rotatable about the axis A in relation to the fixation element and in relation to the catheter hub base part; and
wherein the catheter hub rotatable part is rotatable about the axis A from 0 to 320 degrees.
Nonetheless Lampropoulos, which is within the analogous art of introducer sheaths with rotational components (see abstract), teaches (see Figs. 1A – 1B) wherein the catheter hub rotatable part (112, 150) (see [0027] “side port 112 is attached to head portion 150 and suture ring 145 is attached to base portion 160…This can allow the user to rotate either one or both of suture ring 145 and side port 112 relative to one another”) is rotatable about the axis A in relation to the fixation element (145) and in relation to the catheter hub base part (160) (see Fig. 1B and [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter hub rotatable part and the catheter hub base part of the catheter assembly of Funk in view of a teaching of Lampropoulos such that wherein the catheter hub rotatable part is rotatable about the axis A in relation to the fixation element and in relation to the catheter hub base part. One of ordinary skill in the art would have been motivated to make this modification because Lampropoulos teaches that this configuration allows for easy manipulation of components of the catheter assembly to accommodate both left and right-handed users. Lampropoulos also teaches that the configuration can be adapted to various spatial constraints with minimal efforts. See [0011] of Lampropoulos.
Here, modifying the catheter hub rotatable part and catheter hub base part of the catheter assembly of Funk in view of Lampropoulos would be beneficial because it would allow for the selection between a left handed or right handed configuration of the side channels 216, side port 263 and flexible tubing 265 while retaining the catheter hub base part, the distal locking mechanism 262, within the coupling surface 212 of the fixation element 200. Without the rotational configuration taught by Lampropoulos the distal locking mechanism would rotate as well thereby potentially becoming dislodged from the fixation element. Therefore, a person of ordinary skill would recognize the need and benefit to have the catheter hub rotatable part rotate while the catheter hub base part remains fixed.
The catheter assembly of Funk modified in view of a teaching of Lampropoulos will hereinafter be referred to as the catheter assembly of Funk and Lampropoulos.
However, neither Funk nor Lampropoulos expressly disclose wherein the catheter hub rotatable part is rotatable about the axis A from 0 to 320 degrees.
Nonetheless Abitabilo, which is within the analogous art of catheter systems (see abstract and title), teaches the wing assembly (112), can have a lower modulus of elasticity than the catheter hub (110) thereby enabling the wing assembly to more easily twist and bend to conform to the contours of the skin of the patient (see [0145]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the modulus of elasticity of the stabilization device 200 of the catheter assembly of Funk and Lampropoulos in view of a teaching of Abitabilo such that the stabilization device has a lower modulus of elasticity than the catheter hub. One of ordinary skill in the art would have been motivated to make this modification because having a lower modulus of elasticity enables the stabilization device to easily twist and bend to conform to the contours of the skin of the patient thereby increasing comfort to the patient. See [0145] of Abitabilo.
The catheter assembly of Funk and Lampropoulos modified in view of a teaching of Abitabilo will hereinafter be referred to as the catheter assembly of Funk, Lampropoulos, and Abitabilo.
Here, the catheter assembly of Funk, Lampropoulos, and Abitabilo teaches the catheter hub rotatable part is rotatable about the axis A from 0 to 320 degrees. The stabilization device of the catheter assembly of Funk, Lampropoulos, and Abitabilo limits the catheter hub rotatable part from rotating about the axis A depending upon the modulus of elasticity and flexibility of the stabilization device. When the stabilization device 200 of the catheter assembly of Funk and Lampropoulos is modified to have a lower modulus of elasticity than the catheter hub as taught by Abitabilo, the stabilization device would then limit the rotation of the catheter hub rotatable part about the axis A from 0 to 320 degrees depending upon the contour of the skin of the patient. This rejection is consistent with how the Applicant’s disclosure, see [0040] of the Specification dated 13 October 2022, achieves this functionality.
With regard to claim 2, the catheter assembly of Funk, Lampropoulos, and Abitabilo teaches the claimed invention of claim 1, and Funk further teaches (Figs. 3 – 9) wherein an extension tube (265) (see [0057]) is connected to the coupling element (263) (see [0057] and see Fig. 7).
With regard to claim 5, the catheter assembly of Funk, Lampropoulos, and Abitabilo teaches the claimed invention of claim 1, and Funk further teaches (Figs. 3 – 9) wherein an angle (α) between the coupling element (263) (see [0057]) and a distal end of the catheter hub (see at 261 in Fig. 7) is 160 degrees or smaller than 160 degrees (see [0056] “the side port 263 is substantially perpendicular to a longitudinal axis A defined between the proximal locking mechanism 261 and the distal locking mechanism 262 (see e.g., FIG. 7)” wherein perpendicular is equal to 90 degrees).
With regard to claim 6, the catheter assembly of Funk, Lampropoulos, and Abitabilo teaches the claimed invention of claim 1, and Funk further teaches (Figs. 3 – 9) wherein the catheter hub (260) (see [0045]) further comprises a connection part (261) (see [0061]) at a distal end thereof, configured to be connected to a needle assembly before the catheter assembly is coupled to a patient (see [0061] “Furthermore, the proximal port or locking mechanism 261 of the extension set 260 can be disposed in a proximal position relative to the proximal surface 204 when the extension set 260 is coupled to the coupling surface 212. In this manner, any suitable device can couple to the proximal port or locking mechanism 261 to deliver fluids to, withdraw fluids from, and/or otherwise gain access to the vein in which the IV catheter 250 is disposed” wherein a needle assembly is an example of a suitable device).
With regard to claim 9, the catheter assembly of Funk, Lampropoulos, and Abitabilo teaches the claimed invention of claim 1, and Funk further teaches (Figs. 3 – 9) wherein a catheter tube (250) (see [0045]) is attached to the catheter hub base part (262) (see [0055]).
With regard to claim 10, the catheter assembly of Funk, Lampropoulos, and Abitabilo teaches the claimed invention of claim 1, and Funk further teaches (Figs. 3 – 9) wherein a catheter tube (250) (see [0045]) is attached to the catheter hub base part (262) (see [0055]).
However, Funk is silent with regards to the catheter hub base part being separate from the catheter hub rotatable part, whereby the catheter hub rotatable part is rotatable relative to the fixation element and the catheter hub base part is fixed relative to the fixation element.
Nonetheless Lampropoulos, which is within the analogous art of introducer sheaths with rotational components (see abstract), teaches (see Figs. 1A – 1B) the catheter hub base part (160) being separate from the catheter hub rotatable part (112, 150) (see [0027] “side port 112 is attached to head portion 150 and suture ring 145 is attached to base portion 160…This can allow the user to rotate either one or both of suture ring 145 and side port 112 relative to one another”), whereby the catheter hub rotatable part is rotatable relative to the fixation element (145) and the catheter hub base part is fixed relative to the fixation element (see [0027] and [0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter hub base part and catheter hub rotatable part of the catheter assembly of Funk, Lampropoulos, and Abitabilo in view of a further teaching of Lampropoulos such that the catheter hub base part being separate from the catheter hub rotatable part, whereby the catheter hub rotatable part is rotatable relative to the fixation element and the catheter hub base part is fixed relative to the fixation element. One of ordinary skill in the art would have been motivated to make this modification because Lampropoulos teaches that this configuration allows for easy manipulation of components of the catheter assembly to accommodate both left and right-handed users. Further Lampropoulos teaches that the configuration can be adapted to various spatial constraints with minimal efforts. See [0011] of Lampropoulos.
Here, modifying the catheter hub rotatable part and catheter hub base part of the catheter assembly of Funk, Lampropoulos, and Abitabilo in view of a further teaching of Lampropoulos would be beneficial because it would allow for the selection between a left handed or right handed configuration of the side channels 216, side port 263 and flexible tubing 265 while retaining the catheter hub base part, the distal locking mechanism 262, within the coupling surface 212 of the fixation element 200. Without the rotational configuration taught by Lampropoulos the distal locking mechanism would rotate as well thereby potentially becoming dislodged from the fixation element. Therefore, a person of ordinary skill would recognize the need and benefit to have the catheter hub rotatable part rotate while the catheter hub base part remains fixed.
With regard to claim 23, the catheter assembly of Funk and Lampropoulos teaches the claimed invention of claim 1, however, Funk is silent with regards to the pair of wings are each composed of a flexible, resilient material and are deformable about the A axis from a first position to a second position;
the catheter hub rotatable part is rotatable about the axis A up to 180 degrees when the pair of wings are in the first position; and
the catheter hub rotatable part is rotatable about the axis A up to 320 degrees when the pair of wings are in the second position.
Nonetheless Abitabilo, which is within the analogous art of catheter systems (see abstract and title), teaches the pair of wings (112) are each composed of a flexible resilient material (see [0140] and [0145]) and are deformable about the A axis from a first position to a second position (see [0145]). Additionally, Abitabilo teaches the pair of wings, can have a lower modulus of elasticity than the catheter hub (110) thereby enabling the wing assembly to more easily twist and bend to conform to the contours of the skin of the patient (see [0145]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the stabilization device 200 of the catheter assembly of Funk and Lampropoulos in view of a teaching of Abitabilo such that the stabilization device has a lower modulus of elasticity than the catheter hub. One of ordinary skill in the art would have been motivated to make this modification because having a lower modulus of elasticity enables the stabilization device to easily twist and bend to conform to the contours of the skin of the patient thereby increasing comfort to the patient. See [0145] of Abitabilo.
The catheter assembly of Funk and Lampropoulos in view of a teaching of Abitabilo will hereinafter be referred to as the catheter assembly of Funk, Lampropoulos, and Abitabilo.
Here, the catheter assembly of Funk, Lampropoulos, and Abitabilo teaches the pair of wings are each composed of a flexible, resilient material and are deformable about the A axis from a first position to a second position; the catheter hub rotatable part is rotatable about the axis A up to 180 degrees when the pair of wings are in the first position; and the catheter hub rotatable part is rotatable about the axis A up to 320 degrees when the pair of wings are in the second position. The stabilization device of the catheter assembly of Funk, Lampropoulos, Goral, and Abitabilo limits the catheter hub rotatable part from rotating about the axis A depending upon the modulus of elasticity and flexibility of the stabilization device. When the stabilization device 200 of the catheter assembly of Funk, Lampropoulos, and Abitabilo is modified to have a lower modulus of elasticity than the catheter hub as taught by Abitabilo, the stabilization device would then be deformable from a first position to a second position, the catheter hub rotatable part being rotatable about the axis A up to 180 degrees when the pair of wings are in the first position; and the catheter hub being rotatable about the axis A up to 320 degrees when the wings are in the second position. The first and second positions are the different portions of the body of the patient which the stabilization device 200 is being conformed to. This rejection is consistent with how the Applicant’s disclosure, see [0034] and [0040] of the Specification dated 13 October 2022, achieves this functionality.
Claim(s) 4, 7, 12, 13, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Funk, Lampropoulos, and Abitabilo as applied to claim 1 above, and further in view of Puhasmãgi et al. (US 2014/0221932 A1 hereinafter referred to as “Puhasmãgi”).
With regard to claim 4, the catheter assembly of Funk, Lampropoulos, and Abitabilo teaches the claimed invention of claim 1, however, Funk is silent with regards to wherein the at least one coupling mechanism is an opening circumventing the catheter hub.
Nonetheless Puhasmãgi, which is within the analogous art of catheter introducer assemblies (see abstract), teaches the coupling mechanism (28) (see [0078]) is an opening circumventing the catheter hub (4) (see [0078] and see Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter assembly of Funk, Lampropoulos, and Abitabilo in view of a teaching of Puhasmãgi such that the at least one coupling mechanism is an opening circumventing the catheter hub. One of ordinary skill in the art would have been motivated to make this modification because Puhasmãgi teaches the coupling mechanism comprising an opening circumventing the catheter hub securely connects the fixation element with the catheter hub. See [0078] of Puhasmãgi.
With regard to claim 7, the catheter assembly of Funk, Lampropoulos, and Abitabilo teaches the claimed invention of claim 1, however, Funk is silent with regards to wherein the fixation element is composed of a flexible, resilient material.
Nonetheless Puhasmãgi, which is within the analogous art of catheter introducer assemblies (see abstract), teaches the fixation element (29) (see [0063]) is composed of a flexible, resilient material (see [0078] “The wings can be made in a plastic polymer material.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the fixation element of the catheter assembly of Funk, Lampropoulos, and Abitabilo in view of a teaching of Puhasmãgi such that the fixation element is composed of a flexible, resilient material. One of ordinary skill in the art would have been motivated to make this modification because Funk is silent with regards to what material to construct the fixation element of. Therefore, a person of ordinary skill in the art would refer to a teaching of Puhasmãgi in order to manufacture the device. Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date to compose the fixation element of a plastic material because it has bene held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960); MPEP 2144.07.
With regard to claim 12, the catheter assembly of Funk, Lampropoulos, and Abitabilo of the rejection of Claim 1 above teaches a catheter instrument, comprising the catheter assembly according to claim 1 (see the rejection of Claim 1 above).
However, Funk is silent with regards to the catheter instrument further comprises a needle assembly.
Nonetheless Puhasmãgi, which is within the analogous art of catheter introducer assemblies (see abstract), teaches a needle assembly (3, 23) (see [0059] – [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter instrument of Funk, Lampropoulos, and Abitabilo in view of a teaching of Puhasmãgi such that the catheter instrument further comprises a needle assembly. One of ordinary skill in the art would have been motivated to make this modification because Puhasmãgi teaches that the needle assembly penetrates the patient body to insert a catheter for transferal of blood. See [0008] of Puhasmãgi. A person having ordinary skill in the art would recognize that the needle assembly of Puhasmãgi is as an example of a suitable device that can be coupled to the proximal port or locking mechanism 261 of Funk. See [0061] of Funk.
With regard to claim 13, the catheter assembly of Funk, Lampropoulos, and Abitabilo teaches the claimed invention of claim 1, however, Funk is silent with regards to further comprising a needle.
Nonetheless Puhasmãgi, which is within the analogous art of catheter introducer assemblies (see abstract), teaches a needle (3) (see [0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter assembly of Funk, Lampropoulos, and Abitabilo in view of a teaching of Puhasmãgi such that the catheter assembly further comprises a needle. One of ordinary skill in the art would have been motivated to make this modification because Puhasmãgi teaches that the needle penetrates the patient body to insert a catheter for transferal of blood. See [0008] of Puhasmãgi. A person having ordinary skill in the art would recognize that the needle of Puhasmãgi is as an example of a suitable device that can be coupled to the proximal port or locking mechanism 261 of Funk. See [0061] of Funk.
With regard to claim 25, the catheter assembly of Funk, Lampropoulos, and Abitabilo teaches the claimed invention of claim 1, however, Funk is silent with regards to the at least one coupling mechanism includes an annular body extending circumferentially around the catheter hub relative to the axis A;
the first wing and/or the second wing includes a free end portion projecting axially beyond the annular body and disposed radially spaced apart from the catheter hub; and
a gap is defined by and radially between the free end portion and the catheter hub.
Nonetheless Puhasmãgi, which is within the analogous art of catheter introducer assemblies (see abstract), the at least one coupling mechanism (28) (see [0078]) includes an annular body (see at 28 in Fig. 1) extending circumferentially around the catheter hub (4) (see [0078] and Fig. 1) relative to the axis A.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the at least one coupling mechanism of the catheter assembly of Funk, Lampropoulos, and Abitabilo such that the at least one coupling mechanism includes an annular body extending circumferentially around the catheter hub relative to the axis A. One of ordinary skill in the art would have been motivated to make this modification because Puhasmãgi teaches the first connection mechanism including an annular body that extends circumferentially around the catheter hub securely connects the fixation element with the catheter hub. See [0078] of Puhasmãgi.
The catheter assembly of Funk, Lampropoulos, and Abitabilo modified in view of a teaching of Puhasmãgi.
The catheter assembly of Funk, Lampropoulos, Abitabilo, and Puhasmãgi teaches the following:
the first wing (see at the left 216 in Fig. 5) and/or the second wing (see at the right 216 in Fig. 5) includes a free end portion (see Fig. C reiterated below) projecting axially beyond the annular body (see the 35 U.S.C. § 103 rejection above of Claim 25 where the annotated “at least one coupling mechanism” in Fig. A is amended to be an annular body) and disposed radially spaced apart from the catheter hub (see Fig. D below); and
a gap (see Fig. D below) is defined by and radially between the free end portion and the catheter hub (see Fig. D).
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Claim(s) 11 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Funk, Lampropoulos, and Abitabilo as applied to claims 1 and 10, and further in view of Goral et al. (US 2016/0220805 A1) (hereinafter referred to as “Goral”).
With regard to claim 11, the catheter assembly of Funk, Lampropoulos, and Abitabilo teaches the claimed invention of claim 10, however, Funk is silent with regards to wherein the catheter hub further comprises a seal between the catheter hub rotatable part and the catheter hub base part.
Nonetheless Goral, which is within the analogous art of intravenous catheter assembly designs (see abstract and title), teaches the catheter hub (104) (see [0050]) further comprises a seal (114) (see [0050]) between the catheter hub rotatable part (104B) (see [0056])and the catheter hub base part (104A) (see [0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter hub rotatable part and the catheter hub base part of the catheter assembly of Funk, Lampropoulos, and Abitabilo in view of a teaching of Goral such that the catheter hub further comprises a seal between the catheter hub rotatable part and the catheter hub base part. One of ordinary skill in the art would have been motivated to make this modification because the septum or valve is self-sealing, so that when a needle is withdrawn through the septum, any void left by the withdrawn needle will close and the septum will maintain its fluid impermeability. See [0055] of Goral.
With regard to claim 24, the catheter assembly of Funk, Lampropoulos, and Abitabilo teaches the claimed invention of claim 1, however, Funk is silent with regards to the catheter assembly further comprising a round elastomeric seal located between the catheter hub base portion and the catheter hub rotatable part.
Nonetheless Goral, which is within the analogous art of intravenous catheter assembly designs (see abstract and title), teaches the catheter assembly (100) (see [0050]) further comprising a round elastomeric seal (114) (see [0050]) located between the catheter hub base portion (104A) (see [0050]) and the catheter hub rotatable part (104b) (see [0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter assembly of Funk, Lampropoulos, and Abitabilo in view of a teaching of Goral such that the catheter assembly further comprising a round elastomeric seal located between the catheter hub base portion and the catheter hub rotatable part. One of ordinary skill in the art would have been motivated to make this modification because the septum or valve is self-sealing, so that when a needle is withdrawn through the septum, any void left by the withdrawn needle will close and the septum will maintain its fluid impermeability. See [0055] of Goral.
Claim(s) 14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Funk, Lampropoulos, and Goral.
With regard to claim 14, Funk discloses (see Figs. 3 – 9) a catheter assembly (see Fig. 7) having a longitudinal axis A (A) (see [0056] and Fig. 7), the assembly comprising:
a catheter hub (260) (see [0045]) including a base portion (262) (see [0055]) and a rotatable part (see at 260 in Fig. 7) that is operable to rotate about the axis A in relation to a fixation element (200) (see [0043]);
a coupling element (263) (see [0056]) connected to the catheter hub rotatable part (see [0056]);
wherein the fixation element is connected to the catheter hub and includes a first recess (see at left 216 in Fig. 5) and a second recess (see at right 216 in Fig. 5) configured to fit the coupling element (see [0056]).
However, Funk is silent with regards to:
a seal located between the catheter hub base portion and the catheter hub rotatable part; and
wherein the catheter hub rotatable part is rotatable about the axis A in relation to the fixation element and in relation to the catheter hub base portion.
Nonetheless Lampropoulos, which is within the analogous art of introducer sheaths with rotational components (see abstract), teaches (see Figs. 1A – 1B) wherein the catheter hub rotatable part (112, 150) (see [0027] “side port 112 is attached to head portion 150 and suture ring 145 is attached to base portion 160…This can allow the user to rotate either one or both of suture ring 145 and side port 112 relative to one another”) is rotatable about the axis A in relation to the fixation element (145) and in relation to the catheter hub base part (160) (see Fig. 1B and [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter hub rotatable part and the catheter hub base part of the catheter assembly of Funk in view of a teaching of Lampropoulos such that wherein the catheter hub rotatable part is rotatable about the axis A in relation to the fixation element and in relation to the catheter hub base part. One of ordinary skill in the art would have been motivated to make this modification because Lampropoulos teaches that this configuration allows for easy manipulation of components of the catheter assembly to accommodate both left and right-handed users. Lampropoulos also teaches that the configuration can be adapted to various spatial constraints with minimal efforts. See [0011] of Lampropoulos.
Here, modifying the catheter hub rotatable part and catheter hub base part of the catheter assembly of Funk in view of Lampropoulos would be beneficial because it would allow for the selection between a left handed or right handed configuration of the side channels 216, side port 263 and flexible tubing 265 while retaining the catheter hub base part, the distal locking mechanism 262, within the coupling surface 212 of the fixation element 200. Without the rotational configuration taught by Lampropoulos the distal locking mechanism would rotate as well thereby potentially becoming dislodged from the fixation element. Therefore, a person of ordinary skill would recognize the need and benefit to have the catheter hub rotatable part rotate while the catheter hub base part remains fixed.
The catheter assembly of Funk modified in view of a teaching of Lampropoulos will hereinafter be referred to as the catheter assembly of Funk and Lampropoulos.
However, neither Funk nor Lampropoulos teaches a seal located between the catheter hub base portion and the catheter hub rotatable part.
Nonetheless Goral, which is within the analogous art of intravenous catheter assembly designs (see abstract and title), teaches a seal (114) (see [0050]) located between the catheter hub rotatable part (104B) (see [0056])and the catheter hub base part (104A) (see [0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter hub rotatable part and the catheter hub base part of the catheter assembly of Funk and Lampropoulos in view of a teaching of Goral such that a seal located between the catheter hub base portion and the catheter hub rotatable part. One of ordinary skill in the art would have been motivated to make this modification because the septum or valve is self-sealing, so that when a needle is withdrawn through the septum, any void left by the withdrawn needle will close and the septum will maintain its fluid impermeability. See [0055] of Goral.
The catheter assembly of Funk and Lampropoulos modified in view of a teaching of Goral will hereinafter be referred to as the catheter assembly of Funk, Lampropoulos, and Goral.
With regard to claim 18, the catheter assembly of Funk, Lampropoulos, and Goral teaches the claimed invention of claim 14, and Funk further teaches wherein the fixation element (200) (see [0043]) is wing shaped (see Fig. 3), circular shaped, or rectangular shaped.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Funk, Lampropoulos, and Goral as applied to claim 14 above, and further in view of Abitabilo.
With regard to claim 19, the catheter assembly of Funk, Lampropoulos, and Goral teaches the claimed invention of claim 14, however, Funk is silent with regards to wherein the catheter hub is configured to permit the catheter hub rotatable part to be rotatable about the axis A up to 320 degrees.
Nonetheless Abitabilo, which is within the analogous art of catheter systems (see abstract and title), teaches the wing assembly (112), can have a lower modulus of elasticity than the catheter hub (110) thereby enabling the wing assembly to more easily twist and bend to conform to the contours of the skin of the patient (see [0145]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the modulus of elasticity of the stabilization device 200 of the catheter assembly of Funk, Lampropoulos, and Goral in view of a teaching of Abitabilo such that the stabilization device has a lower modulus of elasticity than the catheter hub. One of ordinary skill in the art would have been motivated to make this modification because having a lower modulus of elasticity enables the stabilization device to easily twist and bend to conform to the contours of the skin of the patient thereby increasing comfort to the patient. See [0145] of Abitabilo.
The catheter assembly of Funk, Lampropoulos, and Goral modified in view of a teaching of Abitabilo will hereinafter be referred to as the catheter assembly of Funk, Lampropoulos, Goral, and Abitabilo.
Here, the catheter assembly of Funk, Lampropoulos, Goral, and Abitabilo teaches the catheter hub rotatable part is rotatable about the axis A from 0 to 320 degrees. The stabilization device of the catheter assembly of Funk, Lampropoulos, Goral, and Abitabilo limits the catheter hub rotatable part from rotating about the axis A depending upon the modulus of elasticity and flexibility of the stabilization device. When the stabilization device 200 of the catheter assembly of Funk, Lampropoulos, Goral, and Abitabilo is modified to have a lower modulus of elasticity than the catheter hub as taught by Abitabilo, the stabilization device would then limit the rotation of the catheter hub rotatable part about the axis A from 0 to 320 degrees depending upon the contour of the skin of the patient. This rejection is consistent with how the Applicant’s disclosure, see [0040] of the Specification dated 13 October 2022, achieves this functionality.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Funk and Lampropoulos as applied to claim 21 above, and further in view of Wilson et al. (US 2011/0071469 A1) (hereinafter referred to as “Wilson”).
With regard to claim 22, the catheter assembly of Funk and Lampropoulos teaches the claimed invention of claim 21, however, Funk is silent with regards to wherein the first connection mechanism and the second connection mechanism are each structured as an annular body that extends circumferentially around the catheter hub relative to the axis A.
Nonetheless Wilson, which is within the analogous art of needle assemblies (see abstract and title), teaches the first connection mechanism (see Examiner annotated Fig. 1 below; hereinafter referred to as “Fig. E”) and the second connection mechanism (see Fig. E below) are each structured as an annular body (see Fig. E below) that extends circumferentially around the hub (40) relative to the axis A.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first and second connection mechanisms of the catheter assembly of Funk and Lampropoulos in view of a teaching of Wilson such that the first connection mechanism and the second connection mechanism are each structured as an annular body that extends circumferentially around the catheter hub relative to the axis A. One of ordinary skill in the art would have been motivated to make this modification because Wilson teaches creating the first and second connection mechanisms as annular bodies that extend circumferentially around the catheter hub securely retains, connects, or couples the hub to the fixation element. See [0098] of Wilson.
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
10/07/2026
