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 2 June 2026 wherein Claims 1 – 17 are amended, Claim 20 is cancelled, no claims are newly added. Therefore Claims 1 – 19 are currently pending.
The Applicant’s amendments to the Claims dated 2 June 2026 has been fully considered. These amendments to the Claims has overcome each Claim Objection set forth in the Non-Final Rejection dated 19 March 2026 (hereinafter referred to as the “Non-Final Rejection”). Therefore, each Claim Objection set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant's arguments filed 2 June 2026 have been fully considered but they are not persuasive.
The Applicant alleges that Balbierz et al. (US 5,814,021 A) (hereinafter referred to as “Balbierz”) does not teach the “intravenous tubing anchor system comprising a tubing and an anchor body, the anchor body…wherein at least a portion of a longitudinal length of the tubing is positioned in the tubing passage and extends through the first end and the second end of the anchor body with the tubing and the anchor body bonded together to resist movement of the tubing relative to the anchor body” as recited within Claim 1. See page 7 of the Applicant’s Remarks dated 2 June 2026. The Examiner respectfully disagrees.
The Applicant alleges that Balbierz does not teach the aforementioned limitation because Balbierz teaches a securing member with an opening that is dilatable between a first dimension adapted to retain the catheter by frictionally engaging the catheter and a second dimension that allows the securing member to be slidably moveable about the catheter. See page 8 of the Applicant’s Remarks dated 2 June 2026.
The Applicant’s argument turns on the broadest reasonable interpretation for the claim limitation “wherein at least a portion of a longitudinal length of the tubing is positioned in the tubing passage and extends through the first end and the second end of the anchor body with the tubing and the anchor body bonded together to resist movement of the tubing relative to the anchor body.”
During patent examination, the pending claims must be “given their broadest reasonable interpretation consistent with the specification. The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard. See MPEP 2111. Under a broadest reasonable interpretation (BRI), words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. The ordinary and customary meaning of a term may be evidenced by a variety of sources, including the words of the claims themselves, the specification, drawings, and prior art. However, the best source for determining the meaning of a claim term is the specification - the greatest clarity is obtained when the specification serves as a glossary for the claim terms. Phillips v. AWH Corp., 415 F.3d 1303, 1315, 75 USPQ2d 1321, 1327 (Fed. Cir. 2005) (en banc) ("[T]he specification ‘is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.’" (quoting Vitronics Corp. v. Conceptronic Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). See MPEP 2111.01.
The Applicant’s specification only recites the term “bonded” one time within [0067]. This paragraph is reiterated in its entirety below.
[0067] Clause 20. The tubing anchor of Clause 17, wherein the tubing and the anchor body are bonded together to resist movement of the tubing relative to the anchor body.
The Applicant’s specification does not provide an explicit definition for what bonding is occurring between the anchor body and the tubing. Therefore the broadest reasonable interpretation for the bonding could be but is not limited to frictional, pressure, or adhesive bonding so long as the end result is that the tubing and the anchor body when bonded together resist movement relative to each other.
Balbierz reads upon the broadest reasonable interpretation of the aforementioned limitation because the dilatable opening of the securing member 110 of Balbeirz provides frictional bonding between the securing member 110 and the catheter 100 such that movement is resisted relative to each other upon removal of the dilator member 140. See Figures 1 – 9, Col. 4, lines 34 – 37, and Col. 5, lines 43 – 57 of Balbierz.
In other words, Balbierz teaches “wherein at least a portion of a longitudinal length of the tubing is positioned in the tubing passage and extends through the first end and the second end of the anchor body with the tubing and the anchor body bonded together to resist movement of the tubing relative to the anchor body” because a portion of a longitudinal length of the catheter 100 is positioned in the tubing passage and extends through the first end and the second end of the securing member 110 with the tubing and the anchor body bonded together to resist movement of the tubing relative to the anchor body through the frictional, compressive engagement of the securing member 110 with the catheter 100 upon removal of the dilator member 140. See Figures 1 – 9, Col. 4, lines 34 – 37, and Col. 5, lines 43 – 57 of Balbierz.
The Applicant’s further argument that modifying Balbierz to include features in which the “anchor body bonded together to resist movement of the tubing relative to the anchor body,” then the principle operation of Balbierz – to provide adjustable securing wings where the “anchoring device can freely move about the catheter cannula 100 and be adjusted at any desired location is moot because no such modification is necessary since Balbierz already teaches this feature. See page 8 of the Remarks dated 2 June 2026.
In view of the aforementioned rationale, the Applicant’s arguments pertaining to Balbierz are unpersuasive. The Applicant reiterates the same arguments for independent Claims 10 and 17 and dependent Claims 2 – 9, 11 – 16, 18, and 19. See pages 9 and 10 of the Remarks dated 2 June 2026. For at least the same reasons recited above the Examiner finds these arguments to be unpersuasive.
As each of the Applicant’s arguments have been found to be unpersuasive, the rejection of Claims 1 – 15, 17, and 19 – 20 under 35 U.S.C. 103 as being unpatentable over Balbierz (US 5,814,021 A) and Liautaud (US 4,015,600 A) as evidenced by Miller (US 2008/0097405 A1) is maintained.
Claim Objections
Claim 14 and 17 are objected to because of the following informalities:
Claim 14 recites “at least one of the top end or the bottom end defines third concave surface.” The Examiner suggests amending this to recite “at least one of the top end or the bottom end defines a third concave surface” to provide antecedent basis for the structure of the third concave surface.
Claim 17 recites “wherein at least a portion of a longitudinal length of the tubing is positioned within the tubing passaged and extends through the first end and the second end of the anchor body with the tubing and the anchor body bonded together to resist movement of the tubing relative to the anchor body.” The Examiner suggests amending this passage to recite “wherein at least a portion of a longitudinal length of the tubing is positioned within the tubing passage and extends through the first end and the second end of the anchor body, [[with]] wherein the tubing and the anchor body are bonded together to resist movement of the tubing relative to the anchor body” to resolve a typographical spelling error of the word “passage” and improve the grammar of the claim language.
Appropriate correction is required.
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 – 15, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balbierz (US 5,814,021 A) and Liautaud (US 4,015,600 A) as evidenced by Miller (US 2008/0097405 A1).
Balbierz and Miller are cited in the Notice of References Cited form dated 20 November 2025.
Liautaud is cited in the Notice of References Cited form dated 19 March 2026.
With regards to claim 1, Balbierz discloses (see Figs. 1 – 9) an intravenous tubing anchor system (see Fig. 1) comprising a tubing (100) (see Col. 4, lines 17 – 40) and an anchor body (110) (see Col. 4, lines 17 – 40), the anchor body (see Examiner annotated Fig. 2 below hereinafter referred to as “Fig. A”) having a first end, a second end, a first sidewall, a second sidewall, a top end, a bottom end, and a tubing passage extending through the first and second ends and defining a longitudinal axis of the anchor body (see Examiner annotated Fig. 7 below hereinafter referred to as “Fig. B”), the first sidewall having front and rear portions that extend away from the longitudinal axis and intersect at an apex of the first sidewall (see Fig. A below where the apex of the first sidewall is located at the annotation titled “First sidewall”), and the second sidewall having front and rear portions that extend away from the longitudinal axis and intersect at an apex of the second sidewall (see Fig. A below where the apex of the second sidewall is at the annotation titled “Second sidewall”),
wherein a width of the anchor body between the apexes of the first and second sidewalls, is greater than a height of the anchor body between the top and bottom ends (see Fig. A below and Figures 2 – 3 and 7), and wherein an outer surface of the top end of the anchor body forms a convex surface (see Fig. B below), the convex surface extending along the longitudinal axis and between the first sidewall and the second sidewall (see Figs. A and B below), and wherein at least a portion of a longitudinal length of the tubing is positioned in the tubing passage and extends through the first end and the second end of the anchor body with the tubing (see Figs 1 – 3, Fig. 7, and Col. 4, lines 17 – 41) and the anchor body bonded together to resist movement of the tubing relative to the anchor body (see Col. 4, lines 17 – 40 “The securing member 110 has a tubular body portion with an opening extending through the tubular body. The opening of the securing member 110 has a diameter sized to retain the catheter cannula 100 by frictionally engaging the catheter cannula 100 such that the securing member 110 is not moveable about the catheter cannula 100.” Where this frictional engagement is frictional bonding).
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However Balbierz is silent with regards to the outer surface of the top end of the anchor body further comprising:
a first concave surface, and a second concave surface, the first concave surface extending adjacent to the convex surface and between the front and rear portions of the first sidewall, and the second concave surface extending adjacent to the convex surface and between the front and rear portions of the second sidewall.
Nonetheless Liautaud, which is within the analogous art of catheter needle assemblies (see abstract and title), teaches the outer surface of the top end of the anchor body (see Fig. 1 and 2) further comprising:
a first concave surface (see Examiner annotated Fig. 2 below hereinafter referred to as “Fig. C”), and a second concave surface (see Fig. C below), the first concave surface extending adjacent to the convex surface (see Fig. C below) and between the front and rear portions of the first sidewall (14) (see Col. 2, lines 21 – 42 and Fig. 1 where the front portion is near reference numeral 13 while the rear portion is near reference numeral 16), and the second concave surface extending adjacent to the convex surface and between the front and rear portions of the second sidewall (14) (see Fig. 1).
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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 outer surface of the top end of the anchor body of the intravenous tubing anchor system of Balbierz in view of a teaching of Liautaud such that the outer surface of the top end of the anchor body further comprises a first concave surface, and a second concave surface, the first concave surface extending adjacent to the convex surface and between the front and rear portions of the first sidewall, and the second concave surface extending adjacent to the convex surface and between the front and rear portions of the second sidewall. One of ordinary skill in the art would have been motivated to make this modification because Miller teaches that a combination of concave and convex surfaces provide for a more ergonomic form for grasping between the clinician’s fingers (see [0024] of Miller).
Additionally, it would have been an obvious matter of design choice to modify the outer surface of the top end of the anchor body of the intravenous tubing anchor system of Balbierz in view of the teaching of Liautaud and evidence of Miller such that the outer surface of the top end of the anchor body further comprises a first concave surface, and a second concave surface, the first concave surface extending adjacent to the convex surface and between the front and rear portions of the first sidewall, and the second concave surface extending adjacent to the convex surface and between the front and rear portions of the second sidewall, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP2144.04(IV)(B).
The intravenous tubing anchor system of Balbierz modified in view of the teaching of Liautaud and evidence of Miller will hereinafter be referred to as the intravenous tubing anchor system of Balbierz, Liautaud, and Miller.
With regards to claim 2, the intravenous tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 1, and Balbierz further teaches (see Figs. 1 – 9) wherein a length of the anchor body between the first and second ends and along the longitudinal axis is greater than the height of the anchor body (see Fig. A and Figs. 2 – 3 and 7).
With regards to claim 3, the intravenous tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 1, and Balbierz further teaches (see Figs. 1 – 9) wherein the front and rear portions of the first sidewall extend toward each other such that a length of the anchor body decreases along the first sidewall in a direction away from the longitudinal axis (see Fig. A above and Figs. 2 – 3).
With regards to claim 4, the intravenous tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 1, and, Balbierz further teaches with regards to wherein the front portion of the first sidewall extends away from the longitudinal axis at a first angle therebetween (see Examiner annotated Fig. 2 below hereinafter referred to as “Fig. D”), and the rear portion of the first sidewall extends away from the longitudinal axis at a second angle therebetween (see Fig. D below)
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However Balbierz is silent with regards to wherein the first angle is greater than the second angle.
Nonetheless it would have been an obvious matter of design choice to modify the first angle such that the first angle is greater than the second angle, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. MPEP 2144.04 (IV)(B); In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Here, a modification of the first angle would adjust the size and shape of the anchor body such that the front portion is larger. A person of ordinary skill in the art would be motivated to make this change in order to properly secure the catheter at a desired location in a patient’s body. Wherein this larger size and shape improves the stability of the anchor body while also providing for easy handling by the clinician.
With regards to claim 5, the intravenous tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 1, and, Balbierz further teaches (see Figs. 1 – 9) wherein the height of the anchor body decreases in a direction away from the longitudinal axis (see Fig. 7).
With regards to claim 6, the intravenous tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 1, and, Balbierz further teaches (see Figs. 1 – 9) wherein the first sidewall extends in a first direction away from the longitudinal axis (see Fig. A above), and wherein the second sidewall extends in a second direction away from the longitudinal axis (see Fig. A above), wherein the second direction is different than the first direction (see Fig. A above).
With regards to claim 7, the intravenous tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 1, and Balbierz further teaches wherein an outer surface along the bottom end of the anchor body forms another convex surface along the longitudinal axis (see Fig. B above).
With regards to claim 8, the intravenous tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 7, however Balbierz is silent with regards to wherein the outer surface of the anchor body along the bottom end defines a third concave surface and a fourth concave surface, the third concave surface extending adjacent to the another convex surface and between the front and rear portions of the first sidewall, and the fourth concave surface extending adjacent to the another convex surface and between the front and rear portions of the second sidewall.
Nonetheless Liautaud, which is within the analogous art of catheter needle assemblies (see abstract and title), teaches the outer surface of the bottom end of the anchor body (see Fig. 1 and 2) further comprising:
an outer surface of the anchor body (see Figs. 1 and 2) along the bottom end defines a third concave surface (see Fig. C above) and a fourth concave surface (see Fig. C above), the third concave surface extending adjacent to the another convex surface (see Fig. C above) and between the front and rear portions of the first sidewall (14) (see Col. 2, lines 21 – 42 and Fig. 1 where the front portion is near reference numeral 13 while the rear portion is near reference numeral 16), and the fourth concave surface extending adjacent to the another convex surface and between the front and rear portions of the second sidewall (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 outer surface of the bottom end of the anchor body of the intravenous tubing anchor system of Balbierz, Liautaud, and Miller in view of a further teaching of Liautaud such that the outer surface of the anchor body along the bottom end defines a third concave surface and a fourth concave surface, the third concave surface extending adjacent to the another convex surface and between the front and rear portions of the first sidewall, and the fourth concave surface extending adjacent to the another convex surface and between the front and rear portions of the second sidewall. One of ordinary skill in the art would have been motivated to make this modification because Miller teaches that a combination of concave and convex surfaces provide for a more ergonomic form for grasping between the clinician’s fingers (see [0024] of Miller).
Additionally, it would have been an obvious matter of design choice to modify the outer surface of the top end of the anchor body of the intravenous tubing anchor system of Balbierz, Liautaud, and Miller in view of the teaching of Liautaud and evidence of Miller such that the outer surface of the anchor body along the bottom end defines a third concave surface and a fourth concave surface, the third concave surface extending adjacent to the another convex surface and between the front and rear portions of the first sidewall, and the fourth concave surface extending adjacent to the another convex surface and between the front and rear portions of the second sidewall, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP2144.04(IV)(B).
With regards to claim 9, the intravenous tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 1, and Balbierz further teaches (see Figs. 1 – 9) wherein a length of the anchor body defined between the front and rear portions of the first sidewall tapers in a direction away from the longitudinal axis (see Fig. A above and Fig. 3).
With regards to claim 10, Balbierz discloses (see Figs. 1 – 9) an intravenous tubing anchor system (see Fig. 1) comprising a tubing (100) (see Col. 4, lines 17 – 41) and an anchor body (110) (see Col. 4, lines 17 – 40), the anchor body (see Fig. A reiterated below) having a first end, a second end, a top end (see Fig. B reiterated below), a bottom end (see Fig. B below), a first wing (see at the annotated “First sidewall” in Fig. A below), a second wing (see at the annotated “Second sidewall” in Fig. A below), and a tubing passage (see Fig. B below) extending through the first and second ends and defining a longitudinal axis of the anchor body, each of the first and second wings comprising a proximal portion adjacent to the longitudinal axis and an apex that is distal to the longitudinal axis (see Fig. A below where the apexes of the first and second wings are at the annotated “First sidewall” and “Second sidewall” and where the proximal portion is along the annotated “Rear portion of the first and second sidewalls”), wherein an outer surface of the top end of the anchor body forms a convex surface, the convex surface extending along the longitudinal axis and between the proximal portion of each of the first and second wings (see Fig. B below); and wherein a width of the anchor body defined between the apexes of the first and second wings is greater than a height of the anchor body between the top and bottom ends (see Fig. A below and Figs. 2 – 3 and 7); and wherein at least a portion of a longitudinal length of the tubing is positioned in the tubing passage and extends through the first end and the second end of the anchor body (see Figs 1 – 3, Fig. 7, and Col. 4, lines 17 – 41), and wherein the tubing and the anchor body are bonded together to resist movement of the tubing relative to the anchor body (see Col. 4, lines 17 – 40 “The securing member 110 has a tubular body portion with an opening extending through the tubular body. The opening of the securing member 110 has a diameter sized to retain the catheter cannula 100 by frictionally engaging the catheter cannula 100 such that the securing member 110 is not moveable about the catheter cannula 100.” Where this frictional engagement is frictional bonding).
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However Balbierz is silent with regards to the outer surface of the top end of the anchor body further comprising:
a first concave surface, and a second concave surface, the first concave surface extending along the proximal portion of the first wing, and the second concave surface extending along the proximal portion of the second wing.
Nonetheless Liautaud, which is within the analogous art of catheter needle assemblies (see abstract and title), teaches the outer surface of the top end of the anchor body (see Fig. 1 and 2) further comprising:
a first concave surface (see Fig. C reiterated below), and a second concave surface (see Fig. C below), the first concave surface extending along proximal portion of the first wing (14)(see Fig. C below at the annotated “first concave surface”), and the second concave surface extending along the proximal portion of the second wing (14) (see Fig. C at the annotated “second concave surface”)
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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 outer surface of the top end of the anchor body of the intravenous tubing anchor system of Balbierz in view of a teaching of Liautaud such that the outer surface of the top end of the anchor body further comprises a first concave surface, and a second concave surface, the first concave surface extending along the proximal portion of the first wing, and the second concave surface extending along the proximal portion of the second wing. One of ordinary skill in the art would have been motivated to make this modification because Miller teaches that a combination of concave and convex surfaces provide for a more ergonomic form for grasping between the clinician’s fingers (see [0024] of Miller).
Additionally, it would have been an obvious matter of design choice to modify the outer surface of the top end of the anchor body of the intravenous tubing anchor system of Balbierz in view of the teaching of Liautaud and evidence of Miller such that the outer surface of the top end of the anchor body further comprises a first concave surface, and a second concave surface, the first concave surface extending along the proximal portion of the first wing, and the second concave surface extending along the proximal portion of the second wing, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP2144.04(IV)(B).
The intravenous tubing anchor system of Balbierz modified in view of the teaching of Liautaud and evidence of Miller will hereinafter be referred to as the intravenous tubing anchor system of Balbierz, Liautaud, and Miller.
With regards to claim 11, the intravenous tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 10, and Balbierz further teaches (see Figs. 1 – 9) wherein a length of the anchor body between the first and second ends and along the longitudinal axis is greater than the height of the anchor body (see Fig. A above and Figs. 2 – 3 and 7).
With regards to claim 12, the intravenous tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 10, and Balbierz further teaches (see Figs. 1 – 9) wherein the height of the anchor body decreases in a direction away from the longitudinal axis (see Fig. 7).
With regards to claim 13, the intravenous tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 10, and Balbierz further teaches (see Figs. 1 – 9) wherein an outer surface along the bottom end of the anchor body forms another convex surface along the longitudinal axis (see Fig. B above).
With regards to claim 14, the intravenous tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 10, however, Balbierz is silent with regards to wherein an outer surface of the anchor body along at least one of the top end or the bottom end defines third concave surface extending along the proximal portion of the first wing, and a fourth concave surface extending along the proximal portion of the second wing.
Nonetheless Liautaud, which is within the analogous art of catheter needle assemblies (see abstract and title), teaches an outer surface of the anchor body (see Figs. 1 – 2) along at least one of the top end or the bottom end defines third concave surface extending along the proximal portion of the first wing (see Fig. C above and Fig. 1), and a fourth concave surface extending along the proximal portion of the second wing (see Fig. C above and 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 outer surface of the bottom end of the anchor body of Balbierz, Liautaud, and Miller in view of a further teaching of Liautaud such that an outer surface of the anchor body along at least one of the top end or the bottom end defines third concave surface extending along the proximal portion of the first wing, and a fourth concave surface extending along the proximal portion of the second wing. One of ordinary skill in the art would have been motivated to make this modification because Miller teaches that a combination of concave and convex surfaces provide for a more ergonomic form for grasping between the clinician’s fingers (see [0024] of Miller).
Additionally, it would have been an obvious matter of design choice to modify the outer surface of the top end of the anchor body of Balbierz, Liautaud, and Miller in view of the teaching of Liautaud and evidence of Miller such that an outer surface of the anchor body along at least one of the top end or the bottom end defines third concave surface extending along the proximal portion of the first wing, and a fourth concave surface extending along the proximal portion of the second wing. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP2144.04(IV)(B).
With regards to claim 15, the intravenous tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 10, and Balbierz further teaches (see Figs. 1 – 9) wherein a length of the anchor body between the first and second ends tapers in a direction away from the longitudinal axis (see Fig. A above and Fig. 3).
With regards to claim 17, Balbierz discloses (see Figs. 1 – 9) an intravenous tubing anchor system (see Fig. 3) comprising:
a tubing (100) (see Col. 4, lines 17 – 40) having a longitudinal length; and
an anchor body (110) (see Col. 4, lines 17 – 40 and Fig. A reiterated below) having a first end, a second end, a first sidewall, a second sidewall, a top end (see Fig. B reiterated below), a bottom end, and a tubing passage extending through the first and second ends and defining a longitudinal axis of the anchor body, the first sidewall having front and rear portions that extend away from the longitudinal axis (see Fig. A reiterated below) and intersect at an apex of the first sidewall (see Fig. A reiterated below at the annotated “First sidewall”), the second sidewall having front and rear portions that extend away from the longitudinal axis (see Fig. A reiterated below) and intersect at an apex of the second sidewall (see Fig. A reiterated below at the annotated “Second sidewall”), wherein a width of the anchor body between the apexes of the first and second sidewalls is greater than a height of the anchor body between the top and bottom ends (see Fig. A below and Figs. 2 – 3 and 7), and an outer surface of the top end of the anchor body forms a convex surface (see Fig. B below), the convex surface extending along the longitudinal axis and between the first sidewall and the second sidewall (see Figs. A and B below);
wherein at least a portion of a longitudinal length of the tubing is positioned within the tubing passaged and extends through the first end and the second end of the anchor body (see Figs 1 – 3, Fig. 7, and Col. 4, lines 17 – 41) with the tubing and the anchor body are bonded together to resist movement of the tubing relative to the anchor body (see Col. 4, lines 17 – 40 “The securing member 110 has a tubular body portion with an opening extending through the tubular body. The opening of the securing member 110 has a diameter sized to retain the catheter cannula 100 by frictionally engaging the catheter cannula 100 such that the securing member 110 is not moveable about the catheter cannula 100.” Where this frictional engagement is frictional bonding).
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However Balbierz is silent with regards to the outer surface of the top end of the anchor body forms a first concave surface, and a second concave surface, the first concave surface extending adjacent to the convex surface and between the front and rear portions of the first sidewall, and the second concave surface extending adjacent to the convex surface and between the front and rear portions of the second sidewall.
Nonetheless Liautaud, which is within the analogous art of catheter needle assemblies (see abstract and title), teaches the outer surface of the top end of the anchor body (see Fig. 1 and 2) further comprising:
a first concave surface (see Fig. C reiterated below), and a second concave surface (see Fig. C below), the first concave surface extending adjacent to the convex surface (see Fig. C below) and between the front and rear portions of the first sidewall (14) (see Col. 2, lines 21 – 42 and Fig. 1 where the front portion is near reference numeral 13 while the rear portion is near reference numeral 16), and the second concave surface extending adjacent to the convex surface and between the front and rear portions of the second sidewall (see Fig. 1).
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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 outer surface of the top end of the anchor body of the intravenous tubing anchor system of Balbierz in view of a teaching of Liautaud such that the outer surface of the top end of the anchor body further comprises a first concave surface, and a second concave surface, the first concave surface extending adjacent to the convex surface and between the front and rear portions of the first sidewall, and the second concave surface extending adjacent to the convex surface and between the front and rear portions of the second sidewall. One of ordinary skill in the art would have been motivated to make this modification because Miller teaches that a combination of concave and convex surfaces provide for a more ergonomic form for grasping between the clinician’s fingers (see [0024] of Miller).
Additionally, it would have been an obvious matter of design choice to modify the outer surface of the top end of the anchor body of the intravenous tubing anchor system of Balbierz in view of the teaching of Liautaud and evidence of Miller such that the outer surface of the top end of the anchor body further comprises a first concave surface, and a second concave surface, the first concave surface extending adjacent to the convex surface and between the front and rear portions of the first sidewall, and the second concave surface extending adjacent to the convex surface and between the front and rear portions of the second sidewall, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP2144.04(IV)(B).
The intravenous tubing anchor system of Balbierz modified in view of the teaching of Liautaud and evidence of Miller will hereinafter be referred to as the tubing anchor system of Balbierz, Liautaud, and Miller.
With regards to claim 19, the tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 17, and Balbierz further teaches (see Figs. 1 – 9) wherein the tubing passage (see Fig. B above) is formed by an inner surface of the anchor body having a cross-sectional width that is transverse relative to the longitudinal axis (see Fig. B), and wherein the cross-sectional width of the tubing passage is approximately equal to or less than a cross-sectional width of an outer surface of the tubing (100) (see Fig. B).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balbierz, Liautaud, and Miller as applied to claim 10, and in view further view of Strouse et al. (US 2019/0224454 A1; hereinafter referred to as “Strouse”).
Strouse is cited in the Notice of References Cited form dated 2 June 2025.
With regards to claim 16, the intravenous tubing anchor system Balbierz, Liautaud, and Miller teaches the claimed invention of claim 10, however, Balbierz is silent with regards to wherein an outer surface of the anchor body comprises an adhesive.
Nonetheless Strouse, which is within the analogous art of tube securing devices and methods of use, teaches (Figs. 22 – 23) an outer surface of the anchor body (20) comprises an adhesive (see [0045] an adhesive pad is attached to the footprint portion 44 at the bottom side 36 of the tube securing device 20” and [0075]).
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 outer surface of the anchor body of the tubing anchor of the intravenous tubing anchor system of Balbierz, Liautaud, and Miller in view of a teaching of Strouse such that an outer surface of the anchor body comprises an adhesive. One of ordinary skill in the art would have been motivated to make this modification because Strouse teaches the adhesive pad attaches the tube securing device to the patient (see [0075] of Strouse). Therefore, it would be beneficial to incorporate an adhesive to the outer surface of the anchor body in order to secure the device to the patient.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balbierz, Liautaud, and Miller as applied to Claim 17 above and in further view of Brimhall et al. (US 2002/0177816 A1; hereinafter referred to as “Brimhall”).
Brimhall is previously cited within the Notice of References Cited form dated 2 June 2025.
With regards to claim 18, the tubing anchor system of Balbierz, Liautaud, and Miller teaches the claimed invention of claim 17, however, Balbierz is silent with regards to wherein a portion of the first and second sidewalls, distal to longitudinal axis, is more flexible, relative to another portion of the anchor body proximal to the longitudinal axis.
Nonetheless Brimhall, which is within the analogous art of catheters having a wing with a stiffening member (see abstract and title), teaches (see Fig. 2) a portion of the first and second sidewalls (26; see [0031] “soft, flexible material used to forms wings 26” wherein the first sidewall is the left wing 26 and the second sidewall is the right wing 26 shown in Fig. 2), distal to longitudinal axis (see the longitudinal axis extending along the catheter 21 in Fig. 2), is more flexible, relative to another portion of the anchor body proximal to the longitudinal axis (27; see [0031] “stiffening members 27 should be more rigid than wings 26”) .
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 anchor body of the intravenous tubing anchor system of Balbierz, Liautaud, and Miller in view of a teaching of Brimhall such that a portion of the first and second sidewalls, distal to longitudinal axis, is more flexible, relative to another portion of the anchor body proximal to the longitudinal axis. One of ordinary skill in the art would have been motivated to make this modification because Brimhall teaches that it is beneficial for a portion of the anchor body to comprise a soft, flexible material while a separate portion comprises a more rigid material. The material variance makes the anchor body comfortable to the touch with no hard portions that could dig into the patient’s skin while providing sufficient rigidity to allow the clinician to precisely control the position and movement of the catheter (see [0005] and [0013] of Brimhall).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
06/28/2026
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