DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 subject matter of Claims 6-8, e.g. the respective lengths, edges, side surfaces…etc. must be shown and labeled 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(s) 7 is/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.
Regarding Claim 7, Applicant recites “the first and second side surfaces extending between the first and second edges” and “a first edge of a first circumferential ring component and a second edge of an adjacent second circumferential ring component”. However, it is unclear if these “first” and “second” edges are the same or different. The specification fails to utilize this terminology and fails to discuss the illustrated embodiments in the same context of the instant claim verbiage. As such, it is unclear what physical structure and relationships are referenced.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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) 2, 3, 5-8, 11, 13, 17, 18, is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication No. 2009/0192496 (“Suwito”) in view of U.S. Publication No. 2007/0225651 (“Rosenberg”), U.S. Patent No. 3,308,819 (“Arp”), and U.S. Patent No. 7,431,710 (“Tu”).
Regarding Claim 2, Suwito discloses a method of using an intravenous cannula device (12, 14), the method comprising:
Inserting a flexible catheter (14) of an intravenous cannula through a skin penetration point (38, 34).
Suwito discloses that insertion of the intravenous catheter device may occur while the intravenous catheter device is removably coupled to an inserter tool (not shown; see Par. 4, 5, 40, 42) such that a needle tip of the inserter tool extends distally of a distal opening in a distal tip of the flexible catheter of the intravenous cannula device, the intravenous cannula device comprising a luer connector at a proximal connector hub (see at 28, 22 – which while not specifically labeled as a “luer” may be immediately recognized by the ordinary artisan as a luer configuration based upon its illustrated arrangement – see Fig. 1) which is maintained external to the skin penetration point.
Suwito discloses removing the inserter tool from the intravenous cannula device such that the needle tip of the inserter tool is slidably withdrawn from a lumen of the flexible catheter (Par. 4, 5, 40, 42) with the flexible catheter remaining in place with the distal opening of the flexible catheter in the target vessel.
Suwito discloses the invention substantially as claimed except that catheter is provided with a “tissue anchor device”. However, Rosenberg discloses that prior art anchoring means may not sufficiently secure a catheter in place and instead of tape, Rosenberg suggests that an invasive tissue anchoring device (24) may be provided as part of the catheter/cannula body such that the tissue anchor device remains external to a target vessel and under a skin layer after insertion of the catheter (see generally Fig. 5, 13) in order to prevent accidental dislodging of the catheter. Rosenberg discloses that the tissue anchor device may be provided as a plurality of elongate components/segments (24, 112) arranged about the circumference of an outer surface of the flexible catheter/cannula, each of the components extending between a first end (i.e. the end affixed to the catheter surface) and a second end (i.e. the free end), the first end coupled to the outer wall of the flexible catheter (see Fig. 1 or 3) and the second end defining an outer edge segment (see Fig. 2, 3A), each of the components spaced apart from an adjacent component (see Fig. 2, 3A) and biased to extend radially outward from the outer wall of the flexible catheter in a first orientation (see Fig. 5 or 8) toward the proximal connector hub and away from the distal tip of the flexible catheter when not subjected to an insertion force (see Fig. 4 or 7) or a withdrawal force (see Fig. 6 or 9), wherein in the first orientation and for each of the components, the second end is closer to the proximal connector hub than the first end in a direction parallel to a longitudinal axis of the flexible catheter (see Fig. 5 or 8). Rosenberg discloses that the flexible catheter and the tissue anchor device of the intravenous cannula device can be removed from a subcutaneous region and through the skin penetration point after the procedure is complete (Abstract), wherein each of the components are configured to shift from the first orientation (Fig. 5 or 8) to a second orientation (Fig. 6 or 9) away from the proximal connector hub and toward the distal tip of the flexible catheter so that the plurality of components prolapse toward the outer wall of the flexible catheter in the second orientation when subjected to the withdrawal force during removal (Par. 44), wherein in the second orientation and for each of the plurality of components, the first end is closer to the proximal connector hub than the second end in a direction parallel to the longitudinal axis of the flexible catheter (see Fig. 6 or 9).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the catheter/cannula of the invention of Suwito with a plurality of circumferentially disposed anchoring segments which are transformable between an insertion shape, a retention shape, and a withdrawal shape, as disclosed by Rosenberg, in order to provide for improved catheter retention helping to limit accidental dislodgement/disruption of catheter insertion during use.
Suwito, as modified by Rosenberg, discloses the invention substantially as claimed except that tissue anchor device is provided as a “slotted circumferential ring comprising a plurality of circumferential ring components arrangement about an outer surface of the flexible catheter with each of the plurality of the circumferential, ring components forming respective segments comprising the first and second ends”. Rather Rosenberg only particularly envisages discrete barbs.
However, Arp discloses a related cannula/catheter device (17) which may have similar, discrete retention barbs (18, 19) which may be configured to prolapse between a retention configuration (see Fig. 4 – in solid) wherein a second, free end of the barb is nearer to the proximal hub of the catheter (see Fig. 1) that a first, fixed end of the barb and a withdrawal configuration (Fig. 4 – phantom) wherein the barbs are prolapsed such that the second, free end is nearer to the distal end of the catheter than the first, fixed end. Arp discloses that other shapes are known and that instead of barbs alternative configurations such as “molded concentric rings” can be used to similar effect (Col. 2, Ln. 65-69) and as such, the ordinary artisan would reasonably recognize that variations as to the shape of the retention features in Rosenberg and modified Suwito can be made with obvious and predictable results inclusive to ring-shaped arrangements while preserving the manner in which they create resiliently transformable retention features able to prolapse/fold over to permit withdrawal.
Arp does not illustrate these “concentric rings” or disclose them particularly to comprise “slotted circumferential rings”. However, Tu discloses a medical device (30) comprising a tubular cannula device which may be provided with various retention/anchoring features including such features as directionally oriented barbs (341), circumferentially disposed rings (333), or slotted, circumferential ring arrangements (323 – see Fig. 57A, B), the slotted circumferential, ring comprising a plurality of circumferential ring components arranged about an outer surface of the cannula shaft (see Fig. 57B), each of the plurality of circumferential ring components configured as an elongate arc segment extending along an outer wall of the cannula shaft in a direction about a circumference of the flexible catheter, each of the plurality of circumferential ring components extending between a first end and a second end, the first end coupled to the outer wall of the flexible catheter and the second end defining an outer edge segment of the circumferential ring component (see Fig. 57B), each of the plurality of circumferential ring components spaced apart from an adjacent component and biased to extend radially outward (see Fig. 57B). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the tissue anchoring device of modified Suwito to comprise a slotted circumferential ring formed as a plurality of circumferential ring components, as disclosed by Tu, whereby such changes in shape are held to be obvious wherein only predicted and expected results are to be obtained, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), wherein the prior art (see Tu and Arp) suggest that variations of directional barbs can be replaced with ring configurations inclusive to slotted ring configurations in order to form a suitable anchoring configuration.
Regarding Claim 3, the tissue device of Suwito, as modified, is configured such that the tissue anchor device includes at least one surface to engage tissue in the subcutaneous region proximate to the skin penetration point (see generally Rosenberg – Fig. 5 or 8).
Regarding Claim 5, Suwito, as modified in view of Rosenberg, Arp, and Tu, provides that the tissue anchor device remains under the skin layer after removing the inserter tool from the intravenous cannula device, and the flexible catheter remains in the targeted vessel to provide fluid communication with the targeted vessel (see Par. 4, 5, 40, 42 – Suwito in view of Fig. 5 and 13 of Rosenberg).
Regarding Claim 6, Suwito, as modified by Rosenberg, Arp, and Tu provides that each of the plurality of circumferential ring components are attached to the outer surface of the flexible catheter along an attachment surface defining a first length and a second length, the first length being non-parallel to and greater than the second length, wherein each of the plurality of circumferential ring components has a first edge circumferentially offset from a second edge by the first length (see Fig. 57B - Tu). Furthermore, it is submitted that such nominal changes to the shape of the slotted retention ring constitute mere obvious design choice inasmuch as the instant specification does not particularly point out or recognize any particular benefit to such design features and it should be understood that such a configuration will perform equally well to various other shaped slotted circumferential rings so as to demonstrate obviousness to such a design, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding Claim 7, Suwito, as modified by Rosenberg, Arp, and Tu, provides that each of the plurality of circumferential ring components include a first side surface opposite a second side surface, the first and second side surfaces extending between the first and second edges along the first length, wherein the plurality of circumferential ring components are spaced apart such that a gap is defined between adjacent circumferential ring components along the outer wall of the flexible, the gap defining a uniform width between a first edge of a first circumferential ring component and a second edge of an adjacent second circumferential ring component for each of the adjacent circumferential ring components along the outer wall of the flexible catheter (see Fig. 57B - Tu). Furthermore, it is submitted that such nominal changes to the shape of the slotted retention ring constitute mere obvious design choice inasmuch as the instant specification does not particularly point out or recognize any particular benefit to such design features and it should be understood that such a configuration will perform equally well to various other shaped slotted circumferential rings so as to demonstrate obviousness to such a design, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding Claim 8, Suwtio, as modified by Rosenberg, Arp, and Tu discloses the first edge and the second edge of each of the plurality of circumferential ring components are circumferentially aligned around the outer surface of the flexible catheter (See Fig. 57B).
Regarding Claim 11, Suwito discloses infusing a fluid from the proximal connector hub through the lumen of the flexible catheter and into the targeted vessel (see Par. 1).
Regarding Claim 13, the tissue device of Suwito, as modified, is configured such that the tissue anchor device includes at least one surface to engage tissue in the subcutaneous region proximate to the skin penetration point (see generally Fig. 5 and 8 of Rosenberg within the context of Suwito).
Regarding Claim 17, Suwito, as modified, discloses the at least one slotted ring (see Tu as it pertains to the use of slotted ring-type retention features) is positioned between the proximal connector hub and the distal opening of the flexible catheter (see Rosenberg – Fig. 13).
Regarding Claim 18, Suwito, as modified, discloses each of the plurality of circumferential ring components defines a first side surface and a second side surface (see Fig. 57B – Tu; see also Fig. 5 and 8 – Rosenberg), wherein the first side surface faces away from the proximal connector hub and the second side surface faces toward the proximal connector hub both (i) before insertion of the tissue anchor device through the skin penetration point (see generally Fig. 1 and 3 of Rosenberg) and (ii) after insertion of the tissue anchor device within the subcutaneous region proximate to the skin penetration point (see generally Fig. 5 and 8 of Rosenberg), wherein the first side surface prolapses toward the outer wall of the flexible catheter when the circumferential ring component is subjected to the withdrawal force during removal (see generally Fig. 6 and 9 of Rosenberg).
Claim(s) 4 and 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication No. 2009/0192496 (“Suwito”) in view of U.S. Publication No. 2007/0225651 (“Rosenberg”), U.S. Patent No. 3,308,819 (“Arp”), and U.S. Patent No. 7,431,710 (“Tu”) as applied above, and further in view of U.S. Publication No. 2012/0078095 (“Heck”).
Regarding Claim 4, Suwito discloses that insertion of the intravenous catheter device can occur while the intravenous catheter device is removably coupled to an inserter tool (not shown; see Par. 4, 5, 40, 42) such that a needle tip of the inserter tool extends distally of a distal opening of the flexible catheter of the intravenous cannula device, the intravenous catheter device comprising a luer connector at a proximal connector hub (see at 28, 22 – which while not explicitly labeled as a “luer connector” would be immediately recognizable as such by the ordinary artisan).
Suwito discloses the invention substantially as claimed except that that the inserter tool comprises an “inserter handle” which extends proximally of the luer connector during insertion. Particularly, Suwito never explicitly illustrates the inserter tool/needle. However, Heck discloses a related intravenous cannula device (10) which is likewise provided to be inserted into the vasculature with the assistance of a needle-type inserter tool (46) which during insertion is provided to be received within the lumen of the intravenous cannula device (see Fig. 12) such that a distal tip (54) of the needle protrudes distally beyond the distal end of the intravenous cannula device (see Fig. 12) and an inserter handle (102) of the inserter tool extends proximally of a luer connector (106, 22) of a proximal connector hub of the intravenous cannula device (see Fig. 12). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the inserter tool of the device of Suwito to have a proximal handle which is provided external to the luer fitting of the hub of the intravenous cannula device, as disclosed by Heck, in order to assist a user in gripping the inserter tool during assembly, insertion, and removal of the tool from the cannula device.
Regarding Claim 10, Suwito, as modified, discloses the invention substantially as claimed except for engaging an external fluid line to the luer connector of the proximal connector hub of the intravenous cannula device to provide fluid connection with the targeted vessel while the catheter remains installed (i.e. the catheter remains in the targeted vessel and the tissue anchor device remains under the skin layer). Rather Suwito only explicitly discusses infusing fluids from an integrally provided Y-site branch (24, 26). However, Heck describes a related catheter arrangement (Fig. 9) which comprises a hub (90) which is provided with a Y-site arrangement (94, 96). Heck describes that the both sites, inclusive to a proximal luer fitting (38) along with the Y-site branch (96) may be engaged with an external fluid line in order to provide for receipt of a plurality of different intravenous fluids (Par. 60) after the catheter has been inserted and the needle removed (Par. 43 – Fig. 9). As such, it would have been obvious for a person having ordinary skill in the art at the time the invention was made, after the catheter has been inserted and the needle removed, engage an external fluid line to the luer connector of the proximal hub of the IV cannula device of modified Suwito, as disclosed by Heck, in order to allow for two infusion fluids to be provided in fluid communication with the targeted vessel when treatment requires such multiple fluid infusions (e.g. a saline infusion paired with an infusion of an intravenous medicament).
Claim(s) 12 and 15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication No. 2009/0192496 (“Suwito”) in view of U.S. Publication No. 2007/0225651 (“Rosenberg”), U.S. Patent No. 3,308,819 (“Arp”), and U.S. Patent No. 7,431,710 (“Tu”) as applied above, and further in view of U.S. Publication No. 2012/0078095 (“Heck”) and U.S. Publication No. 2010/0331821 (“Itou”).
Regarding Claim 12, Suwito, as modified, discloses the invention substantially as claimed except for particularly resolving the axial length of the flexible catheter and the relative length of the connector. However, it is understood that the size of a catheter is a result effective variable pursuant to optimizing the catheter for a particular treatment in a particular patient wherein the physiological dimensions of a patient are known to vary from very small premature neonates to very large adults inclusive to those with medical maladies such as gigantism (see Par. 3, Suwito). Heck describes that such catheters can include configurations 1 to 3 inches long (25.4mm to 76.2mm) in order to be rendered suitable for its art-recognized purpose (Par. 41).
However, neither Suwito nor Heck explicitly resolve the length of the hub. However, Itou discloses that such luer hubs (like those disclosed by Suwito and Heck) are known to comprise lengths of an exemplary 20mm (see Par. 154) or 27mm (Par. 155). As such, it would have been obvious for a person having ordinary skill in the art at the time the invention was made to construct the hub of the invention of Suwito to conform to the same general scale such that the catheter length (see Heck) is longer than the length of the hub (see Itou), thereby establishing a known, suitable scale of the system. It has been held that carrying forward an original patented concept involving only a change in form, proportion, or degree is not such an invention as will sustain patentability, see In re Williams, 36 F.2d 436, 438 (CCPA 1929). It has been held that mere changes in the size/proportion are not generally of the type which will sustain patentability where the prior art device and the claimed device will work equally well, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
Regarding Claim 15, Suwito, as modified, discloses the invention substantially as claimed except that during said inserting, the tissue anchor device of the intravenous cannula device is positioned axially closer to the inserter handle of the inserter tool than to the distal opening of the flexible catheter of the intravenous cannula device.
However, it must be understood that the anchors are positioned within the skin tissue in modified Suwito which resolves a general location where they must reside and as shown in Suwito (see e.g. Fig. 2) the proximal connector hub (which forms the intraoperative connection with the inserter handle) is positioned in close proximity to the insertion site and the skin layer in which the catheter is disposed in order to reduce the exposed length of the catheter which extends beyond the skin surface (Par. 9, 46). Additionally, Suwito discloses that the length of the catheter may be substantially varied (Par. 3), particularly to have a length to the distal tip which is substantially larger than the thickness of the skin tissue (RE: “many centimeters”) thereby demonstrating that it is known, and obvious, to increase the distal length of the catheter which extends into the vasculature and away from the skin tissue surrounding the insertion site (see generally Fig. 2 – consider also Par. 3). As such, Examiner submits that within the context of the disclosure of Suwito, it would have been obvious for a person having ordinary skill in the art at the time the invention was made to locate the anchors (24 – Rosenberg) on the outer surface of the cannula/catheter body (14, 38 – Suwito) at a location nearer to the proximal connector hub (12) (based upon the desired reduction in the length of exposed catheter – Par. 9, 46) and further from the catheter distal opening (i.e. the distal end of 20) (based on variance of the length of the catheter to extend up to “many centimeters” – Par. 3) – thereby only achieving the expected results of simultaneously minimizing exposed catheter length and ensuring that the inserted portion of the catheter is sufficiently long to extend to its desired treatment site (Par. 3, 9, 46 – Suwito).
It has held that rearrangement of the parts of an invention requires only routine and customary skill in the art, see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
It has been held that carrying forward an original patented concept involving only a change in form, proportion, or degree is not such an invention as will sustain patentability, see In re Williams, 36 F.2d 436, 438 (CCPA 1929).
It has been held that mere changes in the size/proportion are not generally of the type which will sustain patentability where the prior art device and the claimed device will work equally well, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
Should Applicant argue that there does not present a presumed scale in the invention of Suwito that the ordinary artisan, being apprised with customary dimensions for catheter hubs would not immediately recognize and appreciate the following is presented. Heck discloses that catheter configurations can be 1 to 3 inches long (25.4mm to 76.2mm) in order to be rendered suitable for its art-recognized purpose (Par. 41). As such, it would have been obvious for a person having ordinary skill in the art at the time the invention was made to construct the catheter of Suwito to have an axial length up to at least 76.2mm, whereby changes in the size/proportion of a catheter system cannot sustain patentability wherein it is well understood to vary the length and diameter of a catheter to render it particularly suited to a specific patient’s physiology for its intended treatment purpose.
Additionally, the prior art (see e.g. Itou) discloses that such luer hubs (like those disclosed by Suwito and Heck) are known to comprise lengths of an exemplary 20mm (see Par. 154) or 27mm (Par. 155). As such, it would have been obvious for a person having ordinary skill in the art at the time the invention was made to construct the hub of the invention of Suwito to conform to the same general scale such that the catheter length is much longer than the length of the hub such that the tissue anchors (being disposed in the skin tissue) will be much closer to the proximal end of the hub (and the handle of the needle) as compared to the distal end of the catheter, in order to utilize a standard sized hub which can accommodate standard sized luer connectors in a known and predictable manner.
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Supplemental Figure: Examiner’s rendering of modified Suwito, installed within the vasculature, using the dimensions as established by the prior art to thus demonstrate the tissue anchors installed within the overlying skin tissue and thus the relative proximity between the anchors and the luer fitting as compared to the distal end of the catheter
Claim(s) 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication No. 2009/0192496 (“Suwito”) in view of U.S. Publication No. 2007/0225651 (“Rosenberg”), U.S. Patent No. 3,308,819 (“Arp”), and U.S. Patent No. 7,431,710 (“Tu”), and U.S. Publication No. 2012/0078095 (“Heck”) as applied above, and further in view of U.S. Patent No. 4,192,305 (“Seberg”).
Regarding Claim 14, Suwito, as modified (see Heck as it pertains to the use of an “inserter handle” to provide the needle to the catheter/cannula device), discloses the invention substantially as claimed except that the needle tip is fixed in position relative to the inserter handle and the inserter tool is threadably engaged with the luer connector of the proximal connector hub. Rather, Heck uses a luer slip type fitting (see Fig. 12).
However, the use of luer-thread fittings is notoriously well-known in the art. For example, Seberg discloses a related cannula device (39) and accompanying inserter tool (11) wherein the handle (12) of the inserter tool is mated to the corresponding hub (35, 40) of the cannula device via a threaded (18) luer fitting (18, 19, 12) which is beneficial for ensuring that the cannula device and inserter tool are locked together during placement to prevent proximal movement of the needle with respect to the catheter during insertion (Col. 4, Ln. 55 – Col. 5, Ln. 3). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the modified invention of Suwito with corresponding luer threaded fittings on the inserter tool to mate to the corresponding luer fitting on the cannula device in place of a slip-type connector, as disclosed by Seberg, in order to ensure that the inserter tool and the cannula device remain fixed together during insertion preventing unintended slipping of the needle from the catheter which might impede insertion by obscuring the sharpened needle tip during the penetration phase of vascular access.
Claim(s) 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication No. 2009/0192496 (“Suwito”) in view of U.S. Publication No. 2007/0225651 (“Rosenberg”), U.S. Patent No. 3,308,819 (“Arp”), and U.S. Patent No. 7,431,710 (“Tu”) as applied above, and further in view of U.S. Publication No. 2011/0112508 (“Panzirer”)
Regarding Claim 16, Suwito, as modified, discloses the invention substantially as claimed except that that the at least one slotted circumferential ring comprises at least two slotted circumferential rings spaced apart along the longitudinal axis defined by the flexible catheter. Arp does appear to suggest that a plurality of rings can be used and that anchoring components can be axially offset from one another (see Fig. 4; see Col. 2, Ln. 65-69). Furthermore, Panzirer discloses a related cannula (100) comprising a plurality of circumferential tissue anchoring rings (114) which are longitudinally spaced apart along the axis of the catheter/cannula (see Fig. 4). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the modified catheter of Suwito with a plurality of axially spaced apart tissue anchoring rings of the slotted type (see Tu), as disclosed by Panzirer, in order to increase the holding strength of the cannula/catheter by providing more retention elements over a larger spatial distance, such duplication of parts being an obvious design choice, see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim(s) 19-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication No. 2009/0192496 (“Suwito”) in view of U.S. Publication No. 2007/0225651 (“Rosenberg”), U.S. Patent No. 3,308,819 (“Arp”), U.S. Patent No. 7,431,710 (“Tu”), and U.S. Publication No. 2012/0078095 (“Heck”).
Regarding Claim 19, Suwito discloses a method of using an intravenous cannula device (12, 14), the method comprising:
Inserting a flexible catheter (14) of an intravenous cannula through a skin penetration point (38, 34).
Suwito discloses that insertion of the intravenous catheter device may occur while the intravenous catheter device is removably coupled to an inserter tool (not shown; see Par. 4, 5, 40, 42) such that a needle tip of the inserter tool extends distally of a distal opening in a distal tip of the flexible catheter of the intravenous cannula device, the intravenous cannula device comprising a luer connector at a proximal connector hub (see at 28, 22 – which while not specifically labeled as a “luer” may be immediately recognized by the ordinary artisan as a luer configuration based upon its illustrated arrangement – see Fig. 1) which is maintained external to the skin penetration point.
Suwito discloses removing the inserter tool from the intravenous cannula device such that the needle tip of the inserter tool is slidably withdrawn from a lumen of the flexible catheter (Par. 4, 5, 40, 42) with the flexible catheter remaining in place with the distal opening of the flexible catheter in the target vessel.
Suwito discloses the invention substantially as claimed except that catheter is provided with a “tissue anchor device”. However, Rosenberg discloses that prior art anchoring means may not sufficiently secure a catheter in place and instead of tape, Rosenberg suggests that an invasive tissue anchoring device (24) may be provided as part of the catheter/cannula body such that the tissue anchor device remains external to a target vessel and under a skin layer after insertion of the catheter (see generally Fig. 5, 13) in order to prevent accidental dislodging of the catheter. Rosenberg discloses that the tissue anchor device may be provided as a plurality of elongate components/segments (24, 112) arranged about the circumference of an outer surface of the flexible catheter/cannula, each of the components extending between a first end (i.e. the end affixed to the catheter surface) and a second end (i.e. the free end), the first end coupled to the outer wall of the flexible catheter (see Fig. 1 or 3) and the second end defining an outer edge segment (see Fig. 2, 3A), each of the components spaced apart from an adjacent component (see Fig. 2, 3A) and biased to extend radially outward from the outer wall of the flexible catheter in a first orientation (see Fig. 5 or 8) toward the proximal connector hub and away from the distal tip of the flexible catheter when not subjected to an insertion force (see Fig. 4 or 7) or a withdrawal force (see Fig. 6 or 9), wherein in the first orientation and for each of the components, the second end is closer to the proximal connector hub than the first end in a direction parallel to a longitudinal axis of the flexible catheter (see Fig. 5 or 8). Rosenberg discloses that the flexible catheter and the tissue anchor device of the intravenous cannula device can be removed from a subcutaneous region and through the skin penetration point after the procedure is complete (Abstract), wherein each of the components are configured to shift from the first orientation (Fig. 5 or 8) to a second orientation (Fig. 6 or 9) away from the proximal connector hub and toward the distal tip of the flexible catheter so that the plurality of components prolapse toward the outer wall of the flexible catheter in the second orientation when subjected to the withdrawal force during removal (Par. 44), wherein in the second orientation and for each of the plurality of components, the first end is closer to the proximal connector hub than the second end in a direction parallel to the longitudinal axis of the flexible catheter (see Fig. 6 or 9).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the catheter/cannula of the invention of Suwito with a plurality of circumferentially disposed anchoring segments which are transformable between an insertion shape, a retention shape, and a withdrawal shape, as disclosed by Rosenberg, in order to provide for improved catheter retention helping to limit accidental dislodgement/disruption of catheter insertion during use.
Suwito, as modified by Rosenberg, discloses the invention substantially as claimed except that tissue anchor device is provided as a “slotted circumferential ring comprising a plurality of circumferential ring components arrangement about an outer surface of the flexible catheter with each of the plurality of the circumferential, ring components forming respective segments comprising the first and second ends. Rather Rosenberg only particularly envisages discrete barbs. However, Arp discloses a related cannula/catheter device (17) which may have similar, discrete retention barbs (18, 19) which may be configured to prolapse between a retention configuration (see Fig. 4 – in solid) wherein a second, free end of the barb is nearer to the proximal hub of the catheter (see Fig. 1) that a first, fixed end of the barb and a withdrawal configuration (Fig. 4 – phantom) wherein the barbs are prolapsed such that the second, free end is nearer to the distal end of the catheter than the first, fixed end. Arp discloses that other shapes are known and that instead of barbs alternative configurations such as “molded concentric rings” can be used to similar effect (Col. 2, Ln. 65-69) and as such, the ordinary artisan would reasonably recognize that variations as to the shape of the retention features in Rosenberg and modified Suwito can be made with obvious and predictable results inclusive to ring-shaped arrangements.
However, Arp does not illustrate these “concentric rings” or disclose them particularly to comprise “slotted circumferential rings”. However, Tu discloses a medical device (30) comprising a tubular cannula device which may be provided with various retention/anchoring features including such features as directionally oriented barbs (341), circumferentially disposed rings (333), or slotted, circumferential ring arrangements (323 – see Fig. 57A, B), the slotted circumferential, ring comprising a plurality of circumferential ring components arranged about an outer surface of the cannula shaft (see Fig. 57B), each of the plurality of circumferential ring components configured as an elongate arc segment extending along an outer wall of the cannula shaft in a direction about a circumference of the flexible catheter, each of the plurality of circumferential ring components extending between a first end and a second end, the first end coupled to the outer wall of the flexible catheter and the second end defining an outer edge segment of the circumferential ring component (see Fig. 57B), each of the plurality of circumferential ring components spaced apart from an adjacent component and biased to extend radially outward (see Fig. 57B). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the tissue anchoring device of modified Suwito to comprise a slotted circumferential ring formed as a plurality of circumferential ring components, as disclosed by Tu, whereby such changes in shape are held to be obvious wherein only predicted and expected results are to be obtained, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), wherein the prior art (see Tu and Arp) suggest that variations of directional barbs can be replaced with ring configurations inclusive to slotted ring configurations in order to form a suitable anchoring configuration.
Regarding Claim 20, Suwito, as modified in view of Rosenberg, Arp, and Tu, provides that in the second orientation the plurality of ring components extend radially outward from the outer wall of the flexible catheter (see Figs. 7-9, Rosenberg; see also Fig. 4, Arp).
Regarding Claim 21, Suwito, as modified, discloses the invention substantially as claimed except for “engaging an external fluid line to the luer connector of the proximal connector hub of the intravenous cannula device to provide fluid connection with the targeted vessel while the catheter remains installed (i.e. the catheter remains in the targeted vessel and the tissue anchor device remains under the skin layer). Rather Suwito only explicitly discusses infusing fluids from an integrally provided Y-site branch (24, 26). However, Heck describes a related catheter arrangement (Fig. 9) which comprises a hub (90) which is provided with a Y-site arrangement (94, 96). Heck describes that the both sites, inclusive to a proximal luer fitting (38) along with the Y-site branch (96) may be engaged with an external fluid line in order to provide for receipt of a plurality of different intravenous fluids (Par. 60) after the catheter has been inserted and the needle removed (Par. 43 – Fig. 9). As such, it would have been obvious for a person having ordinary skill in the art at the time the invention was made, after the catheter has been inserted and the needle removed, engage an external fluid line to the luer connector of the proximal hub of the IV cannula device of modified Suwito, as disclosed by Heck, in order to allow for two infusion fluids to be provided in fluid communication with the targeted vessel when treatment requires such multiple fluid infusions (e.g. a saline infusion paired with an infusion of an intravenous medicament).
Suwito discloses infusing a fluid from the proximal connector hub through the lumen of the flexible catheter and into the targeted vessel (Par. 1).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, consideration of Arp and Tu establishes various known alternatively shaped configurations for the construction of retention bars of the type disclosed by Rosenberg to include ring shaped retention features, including slotted ring-shaped retention features with Arp clearly establishing that ring shaped retention features will prolapse in the same manner as discrete barbs and Tu establishing that slotted ring shaped retention features are an obvious variant of both discrete barbs and wholly circumferential rings. Here the prior art establishes that the changes in shape, as currently claimed, are obvious design choice for affecting the same predictable and expected results and that slotted ring configurations can be employed as alternatives for discrete barbs to operate in the same manner with respect to prolapsing to permit withdrawal.
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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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 07/06/2026
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