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
This Office Action is in response to the Applicant’s amendment filed 15 October 2025 wherein Claims 1, 2, 4 – 11, 14, 15, and 17 – 20 are amended, Claims 3 and 16 are cancelled, and Claims 21 and 22 are newly added. Therefore, Claims 1 – 2, 4 – 15, and 17 – 22 are currently pending within the Application.
The Applicant’s amendments to the Specification dated 15 October 2025 have been considered and entered. The Applicant’s amendments to the Specification dated 15 October 2052 have overcome each Specification Objection set forth in the Non-Final Rejection dated 15 July 2025 (hereinafter referred to as the “Non-Final Rejection”).
The Applicant’s amendments to the Claims dated 15 October 2025 has overcome each Claim Objection set forth in the Non-Final Rejection. Therefore, each Claim Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendments to the Claims dated 15 October 2025 has overcome each Claim Rejection under 35 U.S.C. 112(b) set forth in the Non-Final Rejection. Therefore, each Claim Rejection under 35 U.S.C. 112(b) set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 9 – 12, filed 15 October 2025, with respect to the rejection(s) of independent claim(s) 1, 12, 14, and 20 and their respective dependent claims under 35 U.S.C. §§ 102 and 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 Therefore, the rejection has been withdrawn.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 Funk et al. (US 2018/0344983 A1) and Lampropoulos (US 2006/0142699 A1).
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 1 recites “the at least one coupling mechanism.” Claim 4 recites “the coupling mechanism.” The Examiner suggests amending Claim 4 to recite “the at least one coupling mechanism” to provide proper antecedent basis for this limitation.
Appropriate correction is required.
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.
Claim(s) 7 and 18 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.
Claim 7 recites:
The catheter assembly according to claim 1, wherein the fixation element is composed of a flexible material, a resilient material, a silicone material, and/or a plastic material.
The fixation element being composed of a flexible material, a resilient material, a silicone material, and/or a plastic material 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 at the time the application was filed, had possession of the claimed invention.
Paragraphs [0040] – [0041] of the Specification recites:
[0040] The rotation angle of the catheter rotatable part 115 about the axis A depend on the flexibility of the pair of wings 130 and the surface which they are attached to. For instance, when using a pair of wings 130 of a highly flexible material and when the wings 130 are attached to a thin object, such as a child's finger, the rotation angle may be as high as 320 degrees.
[0041] The pair of wings 130 are made of a flexible, resilient material, for instance a plastic (such as an elastomer) or a silicone.
Originally filed Claim 7 of the Claims dated 13 October 2022 recites:
The catheter assembly according to any one of the preceding claims, wherein the fixation element (130) is made of a flexible, resilient material, preferably a silicone or a plastic.
The Specification does not describe that the fixation element may be composed of a flexible material, a resilient material, a silicone material, and/or a plastic material. Rather as described within paragraphs [0040] – [0041] the fixation element 130 may be comprised of a flexible, resilient material such as plastic or a silicone. Originally filed Claim 7 of the Claims dated 13 October 2022 supports that the fixation element is made of a flexible, resilient material preferably a plastic or silicone. The Applicant’s disclosure has established that plastic and silicone are mutually exclusive species within the genus of flexible, resilient materials. No where within the Applicant’s disclosure is there support for the current claim language of Claim 7. The disclosure recites that the material of the fixation element must be flexible, resilient. However, under the current claim language the material could be a rigid plastic or silicone. Therefore, Claim 7 is 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.
Claim 18 recites:
The catheter assembly according to claim 14, wherein the fixation element is wing shaped, circular shaped, and/or rectangular shaped.
The fixation element being wing shaped, circular shaped, and rectangular shaped 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 at the time the application was filed, had possession of the claimed invention. Paragraph [0038] of the Specification recites (bolded for emphasis):
The disclosed catheter assembly 100 is a closed system, i.e. a system wherein a septum is provided in the catheter hub 110, and fluids are withdrawn or introduced through the lateral extension tube 125. In such systems, the extension tube coupling 120 is commonly placed on a left hand side L, since this simplifies the use of the catheter assembly 100 for right handed people, which in general represent the majority of people. However, for left handed people, the use of such catheter devices are cumbersome and inconvenient. [0039] The pair of wings 130 disclosed herein will act as a fixation element when the catheter assembly 100 is to be attached to the patient. The catheter assembly 100 is for instance attached by covering the wing pair 130 with medical tape which is attached to the skin of the patient. However, such fixation element may have another shape than that of the wing pair 130 and be used together with the catheter hub 110 having a catheter rotatable part 115 as disclosed herein. For instance, each wing of the pair of wings 130 may have a round or rectangular shape.
The Specification does not describe that the fixation element may be wing shaped, circular shaped, and rectangular shaped at the same time. Rather as described within paragraph [0038] the fixation element 130 may be wing shaped, round shaped, or rectangular shaped not all three. Therefore, Claim 18 is 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 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(s) 7 and 18 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 7 recites:
The catheter assembly according to claim 1, wherein the fixation element is composed of a flexible material, a resilient material, a silicone material, and/or a plastic material.
Paragraph [0041] of the Specification recites:
[0041] The pair of wings 130 are made of a flexible, resilient material, for instance a plastic (such as an elastomer) or a silicone.
Originally filed Claim 7 of the Claims dated 13 October 2022 recites:
The catheter assembly according to any one of the preceding claims, wherein the fixation element (130) is made of a flexible, resilient material, preferably a silicone or a plastic.
It is unclear how the fixation element can be composed of a flexible material, a resilient material, a silicone material, and a plastic material all at the same time. The Applicant’s Specification and originally filed Claim 7 has established that plastic and silicone are mutually exclusive species within the genus of flexible, resilient materials. How is it possible to compose the fixation element of mutually exclusive materials at the same time? Therefore, Claim 7 is 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 pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 18 recites (bolded for emphasis):
The catheter assembly according to claim 14, wherein the fixation element is wing shaped, circular shaped, and/or rectangular shaped.
It is unclear how the fixation element can be wing shaped, circular shaped, and rectangular shaped at the same time. Therefore, Claim 18 is 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 pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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) 1, 2, 5, 6, 8 – 10, 14, 15, and 18 – 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 regards 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.
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 regards to claim 2, the catheter assembly of Funk and Lampropoulos 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 regards to claim 5, the catheter assembly of Funk and Lampropoulos 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 regards to claim 6, the catheter assembly of Funk and Lampropoulos 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 regards to claim 8, the catheter assembly of Funk and Lampropoulos teaches the claimed invention of claim 1, however, Funk is silent with regards to wherein the catheter hub rotatable part is rotatable about the axis A between 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) 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 between 0 to 320 degrees (see Figs. 1A – 1B and [0040] “This provides unlimited rotation ability (i.e. 360.degree. degrees), although varying lesser amounts of rotation (i.e. 10-360 degrees) may be provided, depending on a manufacturer's preferences”).
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 and Lampropoulos in view of a further teaching of Lampropoulos such that the catheter hub rotatable part is rotatable about the axis A between 0 to 320 degrees. 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 in view of Lampropoulos would be beneficial because it would allow for the selection between a left handed or right handed configurations of the side channels 216, side port 263 and flexible tubing 265 through rotating about the axis between 0 to 320 degrees 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 regards to claim 9, the catheter assembly of Funk and Lampropoulos 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 regards to claim 10, the catheter assembly of Funk and Lampropoulos 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 and Lampropoulos 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 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.
With regards to claim 14, Funk discloses (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] and [0057]); and
a coupling element (263) (see [0056]) connected to the catheter hub rotatable part (see Fig. 7) ;
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 [0055] and [0057]).
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 portion (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 portion. 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 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 regards to claim 15, the catheter assembly of Funk and Lampropoulos teaches the claimed invention of claim 14, and Funk further teaches (Figs. 3 – 9) the catheter assembly further comprising an extension tube (265) (see [0057]) that is connectable to the coupling element (263) (see [0057] and Fig. 7).
With regards to claim 18, the catheter assembly of Funk and Lampropoulos teaches the claimed invention of claim 14, and Funk further teaches (Figs. 3 – 9) wherein the fixation element (200) (see [0043]) is wing shaped (see Fig. 3), circular shaped, and/or rectangular shaped.
With regards to claim 19, the catheter assembly of Funk and Lampropoulos 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 Lampropoulos, which is within the analogous art of introducer sheaths with rotational components (see abstract), teaches (see Figs. 1A – 1B) the catheter hub is configured to permit 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”) to be rotatable about the axis A up to 320 degrees (see Figs. 1A – 1B and [0040] “This provides unlimited rotation ability (i.e. 360.degree. degrees), although varying lesser amounts of rotation (i.e. 10-360 degrees) may be provided, depending on a manufacturer's preferences.” Wherein within the range of varying lesser amounts of rotation is up to 320 degrees).
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 and Lampropoulos in view of a further teaching of Lampropoulos such that the catheter hub is configured to permit the catheter hub rotatable part to be rotatable about the axis A up to 320 degrees. 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 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 through rotation about the axis A up to 320 degrees 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 regards to claim 20, Funk discloses (see Figs. 3 – 9) a catheter assembly (see Fig. 7), comprising:
a wing-shaped fixation element (200) (see [0043] and see Fig. 3);
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]); 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 and includes at least one recess (see left 216 and right 216 in Fig. 5) that is configured with the coupling element (see Fig. 7).
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 portion (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 portion 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 portion. 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 portion 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 portion, 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 regards to claim 21, the catheter assembly of Funk and Lampropoulos teaches the claimed invention of claim 20, and Funk further teaches (Figs. 3 – 9) the fixation element (200) (see [0043]) includes a first connection mechanism (see Fig. A reiterated below at the left most “at least one coupling mechanism”) and a second connection mechanism (see Fig. A reiterated below at the right most “at least one coupling mechanism”) coupling the fixation element to the catheter hub base portion (262) (see [0055]); and the catheter hub rotatable part (see at 260 in Fig. 7 and [0057]) and the coupling element (263) (see [0056]) are disposed between the first connection mechanism and the second connection mechanism (see Fig. 7).
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Claim(s) 4, 7, 11 – 13, 17, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Funk and Lampropoulos as applied to claims 1, 10, 14, and 21 above, and further in view of Puhasmãgi et al. (US 2014/0221932 A1 hereinafter referred to as “Puhasmãgi”).
Puhasmãgi is cited within the IDS dated 7 May 2024.
With regards to claim 4, the catheter assembly of Funk and Lampropoulos teaches the claimed invention of claim 1, however, Funk is silent with regards to wherein the 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 and Lampropoulos in view of a teaching of Puhasmãgi such that the 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 regards to claim 7, the catheter assembly of Funk and Lampropoulos teaches the claimed invention of claim 1, however, Funk is silent with regards to the fixation element is composed of a flexible material, a resilient material, a silicone material, and/or a plastic 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 material, a resilient material, a silicone material, and/or a plastic 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 and Lampropoulos in view of a teaching of Puhasmãgi such that the fixation element is composed of a plastic 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 regards to claim 11, the catheter assembly of Funk and Lampropoulos 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 Puhasmãgi, which is within the analogous art of catheter introducer assemblies (see abstract), teaches the catheter hub (4) (see [0050]) further comprises a seal (6) (see [0050]) between the catheter hub rotatable part (40) (see [0054]) and the catheter hub base part (41) (see [0054] and Fig. 4a).
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 of the catheter assembly of Funk and Lampropoulos in view of a teaching of Puhasmãgi 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 Puhasmãgi teaches that the valve assembly seals a through passage of the catheter hub thereby preventing inadvertent flow of fluid through the catheter hub. See abstract of Puhasmãgi.
With regards to claim 12, the catheter assembly of Funk and Lampropoulos 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 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 and Lampropoulos 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 regards to claim 13, the catheter assembly of Funk and Lampropoulos teaches the claimed invention of claim 1, however, Funk is silent with regards to the catheter assembly 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 instrument of Funk and Lampropoulos 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 regards to claim 17, the catheter assembly of Funk and Lampropoulos teaches the claimed invention of claim 14, however Funk is silent with regards to the catheter assembly further comprising a seal located between the catheter hub base portion and the catheter hub rotatable part.
Nonetheless Puhasmãgi, which is within the analogous art of catheter introducer assemblies (see abstract), teaches the catheter hub (4) (see [0050]) further comprises a seal (6) (see [0050]) between the catheter hub base portion (41) (see [0054] and Fig. 4a) and the catheter hub rotatable part (40) (see [0054]).
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 of the catheter assembly of Funk and Lampropoulos in view of a teaching of Puhasmãgi such that the catheter assembly further comprising 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 Puhasmãgi teaches that the valve assembly seals a through passage of the catheter hub thereby preventing inadvertent flow of fluid through the catheter hub. See abstract of Puhasmãgi.
With regards 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/or the second connection mechanism includes an annular body that extends circumferentially around the catheter hub relative to the axis A.
Nonetheless Puhasmãgi, which is within the analogous art of catheter introducer assemblies (see abstract), teaches the first connection mechanism (28) (see [0078]) and/or the second connection mechanism (“or” conjunction makes this limitation regarding the second connection mechanism optional) includes an annular body (see at 28 in Fig. 1) that extends 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 catheter assembly of Funk and Lampropoulos in view of a teaching of Puhasmãgi such that the first connection mechanism includes an annular body that extends circumferentially around the catheter hub relative to 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chelak et al. (US 2019/0275297 A1) previously cited in the Notice of References Cited form dated 15 July 2025.
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.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
01/02/2026
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