DETAILED ACTION
Claim Rejections - 35 USC § 112
1. 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.
2. Claims 1-16 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 1, from which claims 2-16 depend, the term “the extension set” (line 2) lacks proper antecedent basis in the claims.
Claim Rejections - 35 USC § 102
3. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
4. Claims 1-2, 12-13, and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US
2021/0299426 (Scherich).
Regarding claim 1, Scherich teaches an instrument delivery device for introducing an instrument into a patient's vascular system via a catheter assembly including a primary catheter (100 to introduce 110 through 200 including 223, Fig. 2; extension set provides support, alignment, and aseptic delivery of the instrument 110 through the catheter assembly and into the patient's vascular system, para [0052]; catheter assembly 200 includes a catheter 223, para [0070]), the extension set comprising:
an extension tube (102, Fig. l; extension set 100 may include tube 102, para [0052]) comprising a proximal end (104, Fig. 1), a distal end (106, Fig. 1), and an outer tube wall that defines a tube lumen (see 108 defining lumen of 102, Fig. 1; tube 102 which may includes a proximal end 104, a distal end 106, and an outer surface 108 ... instrument may be disposed within the tube 102, para [0052]); and
an instrument disposed within the tube lumen and comprising a proximal end and a distal end (see 110 disposed with lumen of 102 with 112 and 114, Fig. 1; instrument 110 may be disposed within the tube 102 and may include a proximal end 112 and a distal end 114, para [0052]), the instrument movable within the tube lumen to an advanced position where the distal end of the instrument extends into the primary catheter or beyond a distal tip thereof (see movement of 110 within lumen of 102 Fig. 3 to Fig. 4; movement of the translation handle along the outer surface of tube 102 translates the distal end 114 of the instrument 110 between the retracted position, shown in Fig. 3, and the advanced position, shown in Fig. 4, para [0074]; see 114 of 110 extending between a distal tip of 223 when advanced, Fig. 2; the instrument 110 may extend through the distal end of the catheter assembly in response to the translation handle moving to the distal position, para [0055]);
wherein the proximal end of the instrument comprises a retaining feature having a first outer diameter greater than a second outer diameter of the distal end of the instrument (see example of 117 at 112 of 110, Fig. l; see example of 117 with a diameter greater than a diameter of 110 at 114, Fig. 4; coupler element 117 may engage with one or more features of the translation handle to allow translation of the instrument 110 without any direct contact between the translation handle and the coupler element 117 coupled to instrument 110, para [0075]), the retaining feature comprising a reinforcing structure that prevents deformation of the retaining feature (the coupler element 117 may include ribs to facilitate fluid flow ... longitudinal ribs may be molded onto an outer surface of the coupler element 117, para [0078] [0079]; Note: "prevents deformation of the retaining feature" is considered an intended use. Scherich 's ribs are considered capable of "prevents deformation of the retaining feature" since ribs are a reinforcing structure which could contribute to the preventing the deformation of the retaining feature).
Regarding claim 2, Scherich teaches the instrument delivery device of claim 1, wherein the instrument comprises a secondary catheter defining a catheter lumen extending between the proximal end and the distal end thereof (instrument 110 may include tubing to provide fluid infusion which may include a standard catheter tip, para [0057]).
Regarding claim 12, Scherich teaches the instrument delivery device of claim 2, further comprising a distal connector positioned at the distal end of the extension tube to connect the extension tube to the catheter assembly (see example of 212 coupling 102 to 200, Fig. 2; distal connector 212 couples the extension set 100 to the catheter assembly 200, para [0070]; distal connector 212 at the distal end 106, para [0082]).
Regarding claim 13, Scherich teaches the instrument delivery device of claim 2, further comprising a proximal connector positioned at the proximal end of the extension tube (209, Fig. 2; proximal connector 209 integrated with or coupled to proximal end 104 of tube 102, para [0061]), the proximal connector configured to engage a fluid delivery device that delivers fluid to the catheter assembly through the secondary catheter (see 209 engaged with 206/208, Fig. 2; there may be a tight fit or septum between extension tube 206 and proximal connector 209 which creates a seal but allow motion of 206 relative to 209, para [0061]; proximal connector 208 may be coupled to or integrated with the proximal end of the extension tube 206 to connect to an infusion device, para [0059]; instrument 110 may include tubing to provide fluid infusion, para [0057]).
Regarding claim 15, Scherich teaches the instrument delivery device of claim 1, further comprising a translation handle coupled to an outer surface of the outer tube wall (see 116 coupled to the outer surface of 108, Fig. 1; translation handle 116 may be coupled to the outer surface of the tube 102, para [0053]), wherein the translation handle is configured to move along the outer surface of the outer tube wall between a proximal position and a distal position to translate the distal end of the instrument between a retracted position and the advanced position (see movement of 116 along 102 from Fig. 3 to Fig. 4; 116 may move along a length of the outer surface of the tube between a proximal position and distal position ... translation handle 116 may translate the distal end 114 of the instrument between a retracted position and an advanced position, para [0053]-[0054]).
Regarding claim 16 Scherich teaches the instrument delivery device of claim 15, wherein the translation handle, engages the retaining feature through the outer tube wall, to provide for movement of the instrument between the retracted position and the advanced position (see 116 engaging 117 through 108, Fig. SA; coupler element 117 may engage with translation 116 through the tube 102 to allow for translation of instrument 110 with any direct contact between 116 and 117, para [0075]).
Regarding claim 17, Becton teaches a vascular access system (100 and 200 with 223, Fig. 2; extension set may provide needle free delivery of the instrument to a patient's vascular system by utilizing an existing vascular access device such as the catheter 223, para [0072]; catheter assembly 200, para [0055]) comprising:
a catheter assembly (200, Fig. 2) including:
a catheter adapter (220, Fig. 2; catheter adapter 220, para [0070]) comprising a distal adapter port (221, Fig. 2; distal end 221, para [0070]), a proximal adapter port (222, Fig. 2; proximal end 222, para [0070]), and a side adapter port (224, Fig. 2; side port 224, para [0070]);
a primary catheter coupled to the distal adapter port and configured to be inserted into a patient's vasculature (see 223 coupled to 221, Fig. 2; a catheter 223 may be secured within the catheter adapter 220 and extend distally from the distal end 221 ... peripheral IV catheter, para [0070]); and
a near patient connector coupled to the side adapter port via a first fluid conduit (see unlabeled T-adapter coupled to 224 via a first tube, Fig. 2; side port 224, from which another extension tube may extend ... the other extension tube may be coupled to a T-adapter, para [0070]), the near patient connector comprising a distal connector port (see port of T-adapter which is coupled to the tube which is coupled to 224, Fig. 2), a proximal connector port (see port of T-adapter coupled to 212, Fig. 2; distal connector 212 may be coupled
to the adapter, para [0070]), and a side connector port (see lower side port of the T-adapter, Fig. 2); and
the instrument delivery device of claim 1 (100, Fig. 2), with the extension tube coupled to the near patient connector at the proximal connector port (see 102 coupled to the T -adapter via 212 at the proximal port, Fig. 2; distal connector 212 couples the extension set 100 to the catheter assembly 200 ... distal end 106 of 100 may be coupled to the adapter, para [0070]).
Regarding claim 18, Scherich teaches the vascular access system of claim 17, further comprising an extension set integrated with the near patient connector at the side connector port, the extension set comprising a second fluid conduit for providing fluid to the catheter assembly (see unlabeled extension set integrated with the side port of the T -adapter and including a fluid conduit in communication with remainder of 200, Fig. 2; intended use: reasonably assuming such extension set coupled to the side port of the T -adapter can provide fluid to the remainder of 200 via the coupler at the end of the extension set).
Regarding claim 19, Scherich teaches the vascular access system of claim 17, wherein the extension tube is integrated with the near patient connector at the proximal connector port (referring to Fig. 2 ... extension set 100 may be permanently integrated with the catheter assembly 200, para [0055]).
Regarding claim 20, Scherich teaches the vascular access system of claim 17, wherein the extension tube is coupled to the near patient connector at the proximal connector port via one of a luer connector (see 102 coupled to the T-adaptor via 212, Fig. 2; distal connector 212 may include a male or female luer, para [0060]) and a lock comprising a blunted cannular and a pair of locking arms (capable of use in the intended manner of connecting to such devices).
Claim Rejections - 35 USC § 103
5. 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.
6. Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0226313 (Burkholz) in view of US 2024/0075248 (Burkholz ‘248).
Regarding claim 1, Burkholz teaches an instrument delivery device for introducing an instrument into a patient's vascular system via a catheter assembly including a primary catheter (see 22/32 to deliver 26 via 12 including 16, Fig. 2-3; catheter adapter 12 having a primary catheter 16 to be inserted into a patient's vasculature ... a secondary lumen 22 in fluid communication with the primary catheter 26 ... a mid-line lumen 26 at least partially received within secondary lumen 22 ... movement of the advancement member 32 moves the mid-line lumen 26 between the retracted position (Fig. 2) and the extended position (Fig. 3), the advancement member configured to move along an outer surface of the secondary lumen 22, para [0056]-[0057]), the extension set comprising:
an extension tube (22, Fig. 2-3 and 16; secondary lumen 22, para [0057]) comprising a proximal end (end of 22 with 24, Fig. 2-3; secondary lumen port 24, para [0056]), a distal end (end of 22 with 62, Fig. 2-3; joining connector 62, para [0058]), and an outer tube wall that defines a tube lumen (see wall of 22 which defines lumen of 22, Fig. 16; advancement member is configured to move along an outer surface of the secondary lumen 22, para [0057]); and
an instrument disposed within the tube lumen (see 26/40 disposed within 22, Fig. 1-2 and 16; utilize midline lumen 26 for blood draw and administering medication, para [0056]; mid-line lumen 26 attached to coupler 40, para [0057]) and comprising a proximal end (see end of 26 coupled to 32 opposite of 28, Fig. 1-3; see end of26 with 40 surrounded by 32, Fig. 16; mid-line lumen 26 attached to coupler 40, para [0057]; distal end 28 of the mid-line lumen 26, para [0056]) and a distal end (28, Fig. 3; distal end 28 of the mid-line lumen 26, para [0056]), the instrument movable within the tube lumen to an advanced position where the distal end of the instrument extends into the primary catheter or beyond a distal tip thereof (see movement of 26 from Fig. 2 to Fig. 3 where 28 of 26 extends beyond 30 of 16 in Fig. 3; mid-line lumen 26 has a retracted position (Fig. 2) and an extended position (Fig. 3) where the distal end 28 of mid-line lumen 26 extends beyond the distal end 30 of the primary catheter 16, para [0056]);
wherein the proximal end of the instrument comprises a retaining feature having a first outer diameter greater than a second outer diameter of the distal end of the instrument (see 40 at the proximal end of 26 with a first outer diameter greater than the outer diameter of the remainder of 26, Fig. 16; coupler 40 is positioned between ball bearings, movement of ball bearings engages the coupler, para [0057]).
Burkholz does not specifically teach the retaining feature comprising a reinforcing structure that prevents deformation of the retaining feature.
However, Burkholz does further teach the coupler is used to engage the ball bearings of the advancement member (see 40 between 38(s) of 32, Fig. 16; coupler 40 is positioned between the ball bearings 38. movement of advancement member 32 causes ball bearings 38 to engage the coupler, thereby moving the coupler 40 and mid-line lumen 26 along with the advancement member 32, para [0057]).
In addition, in similar art, Burkholz '248 teaches an inner housing to be pushed through an outer housing (see 118 to be pushed through 116, Fig. IA to lB; inner housing 118 slidably received within outer housing 116, para [0047]), wherein the inner housing can comprise a flexible material with one or more portions of rigid material arranged therein or thereon (rigid material 117 ... may be provided at any location with any suitable arranged to provide adequate flexibility and pushability of inner housing 118, para [0057]; see 117 and 318 as different examples of rigid material, Fig. 5A-5B-l; rigid material 318 arranged in different configurations, para [0058]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Burkholz, the rigid material of Burkholz '248 on the proximal end, including the connector, of the mid-line catheter of Burkholz, motivated by the benefit of reducing the chance of the mid-line catheter kinking during advancement and ensure the connector can't be deformed in order to reduce the chances of allowing the ball bearings to slip out of engagement with the connector or cause the connector to pinch the mid-line catheter within, having a predictable outcome absent a teaching of an unexpected result. See KSR International Co. v. Teleflex Inc. et al., 550 U.S. 2007 at 13, lines 22-25 which states, “When a work is available in one field of endeavor, design incentives ...can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”.
Regarding claim 2, Burkholz and Burkholz ‘248 teach the instrument delivery device of claim 1, and Burkholz further teaches wherein the instrument comprises a secondary catheter defining a catheter lumen extending between the proximal end and the distal end thereof (the vascular access system is configured to utilize mid-line lumen 26 for blood draw and administering medication while also providing the option of simultaneously infusing fluids through the primary lumen, para [0056]; reasonably assuming a lumen used for blood draw is a catheter, which is used alongside a primary lumen, making it a secondary catheter).
Regarding claim 3, Burkholz and Burkholz ‘248 teach the instrument delivery device of claim 2, and Burkholz further teaches wherein the retaining feature comprises a tapered portion that flares radially outward from the second outer diameter [to] the first outer diameter (see inner tapered walls of 40 as tapered portion which flare radially outward from the outer diameter of 26 toward the outer diameter of 40, Fig. 16), with the tapered portion having an increased wall thickness greater than a wall thickness of a remainder of the secondary catheter, thereby forming the reinforcing structure (see thickness of inner tapered walls of 40 as greater than remainder of 26, Fig. 16), but Burkholz does not specifically teach the tapered portion flaring radially outward from the second outer diameter to the first outer diameter, instead Burkholz only teaches the tapered portion flaring towards the second outer diameter.
However, it is commonly known in the art optimizing shape could have been used to change the taper such that it would reach all the way to the second diameter.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to change the shape and/or size of the coupler such that the tapered inner portion of the coupler extends entirely to the outer diameter of the coupler, in order to allow for a broader opening into the tapered portion for easier insertion of tubing, having a predictable outcome absent a teaching of an unexpected result.
A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). See MPEP 2144.04 (IV)(B).
A change in size, absent a teaching of an unexpected result, is within ordinary skill in the art. See MPEP 2144.04(IV)(A):
In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package “of appreciable size and weight requiring handling by a lift truck” where held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (“mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled.” 531 F.2d at 1053, 189 USPQ at 148.).
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In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Regarding claim 4, Burkholz and Burkholz ‘248 teach the instrument delivery device of claim 3, and Burkholz further teaches wherein the tapered portion having the increased wall thickness forms a funnel structure defining a shaped opening into the catheter lumen (see tapered portion with increased wall thickness of 40 forming a funnel structure into lumen of 26, Fig. 16).
Regarding claim 5, Burkholz and Burkholz ‘248 teach the instrument delivery device of claim 2, and Burkholz ‘248 further teaches wherein the reinforcing structure comprises a stiffening component formed of a stiffening material having a stiffness greater than a stiffness of material from which the secondary catheter is formed (inner housing may be formed of a flexible material 118, with one or more rigid material 117 arranged thereon, para [0057]; Burkholz teaches the mid-line lumen 26 may be formed from a flexible material, para [0071]; when the rigid material of Burkholz ‘248 is applied to the mid-line lumen and connector of Burkholz, the rigid material of Burkholz ‘248 would have a stiffness greater than the midline lumen).
Regarding claim 6, Burkholz and Burkholz ‘248 teach the instrument delivery device of claim 5, and Burkholz ‘248 further teaches wherein the stiffening component is affixed to the secondary catheter via one of adhesive bonding (rigid material 117 may be secured to flexible material with an adhesive, para [0057]), welding, or swaging.
Regarding claim 7, Burkholz and Burkholz ‘248 teach the instrument delivery device of claim 5, and Burkholz further teaches wherein the retaining feature comprises a tapered portion that flares radially outward from the second outer diameter [to] the first outer diameter (see inner tapered walls of 40 as tapered portion which flare radially outward from the outer diameter of 26 toward the outer diameter of 40, Fig. 16), and wherein the stiffening component is positioned within the catheter lumen, in the tapered portion (Burkholz ‘248 teaches the rigid material may be arranged about an inner surface of flexible material, para [0058], such that application of the rigid material of Burkholz ‘248 on the mid-line lumen and connector of Burkholz would apply the rigid material to the interior of the mid-line lumen and tapered portion of the connector of Burkholz), but Burkholz does not specifically teach the tapered portion flaring radially outward from the second outer diameter to the first outer diameter, instead Burkholz only teaches the tapered portion flaring towards the second outer diameter.
However, it is commonly known in the art optimizing shape could have been used to change the taper such that it would reach all the way to the second diameter.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to change the shape and/or size of the coupler such that the tapered inner portion of the coupler extends entirely to the outer diameter of the coupler, in order to allow for a broader opening into the tapered portion for easier insertion of tubing, having a predictable outcome absent a teaching of an unexpected result.
A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). See MPEP 2144.04 (IV)(B).
A change in size, absent a teaching of an unexpected result, is within ordinary skill in the art. See MPEP 2144.04(IV)(A):
In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package “of appreciable size and weight requiring handling by a lift truck” where held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (“mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled.” 531 F.2d at 1053, 189 USPQ at 148.).
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In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Regarding clam 8, Burkholz and Burkholz ‘248 teach the instrument delivery device of claim 7, and Burkholz ‘248 further teaches wherein the stiffening component defines an opening into the catheter lumen (see 318 applied within 218 defining at opening, Fig. 5B-1; rigid material arranged about an inner surface of flexible material 218, para [0058]; reasonably assuming when the rigid material is arranged about the interior of the tapered portion of Burkholz, the rigid material would define an opening to the mid-line lumen), the opening having a reduced opening area as compared to an opening area defined by the tapered portion (see open area defined by 218 as greater than open area defined by 318, Fig. 5B-1; reasonably assuming a similar reduction in open area would occur when the rigid material of Burkholz ‘248 is applied to the internal tapered surface of Burkholz).
Regarding claim 9, Burkholz and Burkholz ‘248 teach the instrument delivery device of claim 7, and Burkholz further teaches wherein the stiffening component forms one of a wedge-shaped stiffening member, a ring-shaped stiffening member, and a frustoconical-shaped stiffening member (see frustoconical shape of interior of 40, Fig. 16; reasonably assuming when rigid material of Burkholz ‘248 is applied to the interior of the tapered portion of Burkholz the rigid material would take on the frustoconical shape to match the tapered portion and not affect the intended use).
Regarding claim 10, Burkholz and Burkholz ‘248 teach the instrument delivery device of claim 5, and Burkholz further teaches wherein the stiffening component is positioned about the secondary catheter (see part of the tapered portion of 40 positioned about 26, Fig. 16; reasonably assuming when the rigid material of Burkholz ‘248 is applied on 40 of Burkholz the rigid material would then be positioned about the mid-line lumen 26).
7. Claims 1-2 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0088022 (Burkholz '022) in view of US 2024/0075248 (Burkholz ‘248).
Regarding claim 1, Burkholz ‘022 teaches an instrument delivery device for introducing an instrument into a patient's vascular system via a catheter assembly including a primary catheter (see 10 to introduce 12 via 38 including 48, Fig. 3A-B; a catheter delivery device 10 may facilitate delivery of a secondary catheter 12 through a catheter assembly and into vasculature of a patient, para [0055]; catheter assembly 38 may include the primary catheter 48, para [0066]), the extension set comprising:
an extension tube (14, Fig. lA-D; housing 14, para [0055]; housing may include an extension tube, para [0064]) comprising a proximal end (18, Fig. lA-D), a distal end (16, Fig. lA-D), and an outer tube wall that defines a tube lumen (see wall of 14 defining 20, Fig. lA-D; a housing lumen 20 extending through housing distal end 16 and housing proximal end 18, para [0055]); and
an instrument disposed within the tube lumen (12 with 20, Fig. lA-D; secondary catheter 12 may be loose or unattached within the housing lumen 20, para [0056]) and comprising a proximal end and a distal end (24 and 22, Fig. lA-D; 12 may include a secondary catheter distal end 22 and a secondary catheter proximal end 24, para [0056]), the instrument movable within the tube lumen to an advanced position where the distal end of the instrument extends into the primary catheter or beyond a distal tip thereof (see movement of 12 within 20 from Fig. lA and lB to Fig. lC and 1D; see 12 not extending through 48 in Fig. 3A and then extending through beyond 50 of 48 in Fig. 3B; 12 may be configured to move distally to an advanced position in response to fluid pressure provided by a fluid delivery source, para [0057]; Fig. 3B illustrates a view of the catheter system of Fig. 3A after fluid infusion, para [0033]);
wherein the proximal end of the instrument comprises a retaining feature having a first outer diameter greater than a second outer diameter of the distal end of the instrument (see diameter of 32 at 24 of 12 as greater than the diameter of 12 at 22, Fig. lB; secondary catheter 12 may include an expanded portion 32 ... the portion of the housing lumen may contact the expanded portion 32 when the secondary catheter is disposed in the advanced position and may act as a stop to prevent distal movement of the secondary catheter, para [0062]), but Burkholz ‘022 does not specifically teach the retaining feature comprising a reinforcing structure that prevents deformation of the retaining feature. However, in similar art, Burkholz ‘248 teaches an inner housing to be pushed through an outer housing (see 118 to be pushed through 116, Fig. lA to lB; inner housing 118 slidably received within outer housing 116, para [0047]), wherein the inner housing can comprise a flexible material with one or more portions of rigid material arranged therein or thereon (rigid material 117 ... may be provided at any location with any suitable arranged to provide adequate flexibility and pushability of inner housing 118, para [0057]; see 117 and 318 as different examples of rigid material, Fig. 5A-5B-1; rigid material 318 arranged in different configurations, para [0058]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Burkholz, providing a rigid material on the proximal, expanded portion of the secondary catheter as taught by Burkholz ‘248, motivated by the benefit of ensuring the expanded portion maintains its shape during application of the fluid for proper advancement of the secondary catheter and also ensuring the expanded portion has a rigid engagement with the end of housing lumen to ensure it properly stops advancement of the secondary catheter, having a predictable outcome absent a teaching of an unexpected result. See KSR International Co. v. Teleflex Inc. et al., 550 U.S. 2007 at 13, lines 22-25 which states, “When a work is available in one field of endeavor, design incentives ...can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”.
Regarding claim 2, Burkholz ‘022 and Burkholz ‘248 teach the instrument delivery device of claim 1, Burkholz ‘022 teaches wherein the instrument comprises a secondary catheter defining a catheter lumen extending between the proximal end and the distal end thereof (12 with 26, Fig. lB; secondary catheter 12 includes a secondary catheter lumen extending through 22 and 24, para [0056]).
Regarding claim 13, Burkholz ‘022 and Burkholz ‘248 teach the instrument delivery device of claim 2, and Burkholz ‘022 further teaches comprising a proximal connector positioned at the proximal end of the extension tube, the proximal connector configured to engage a fluid delivery device that delivers fluid to the catheter assembly through the secondary catheter (see 30 engaging 60, Fig. IA and 3A; proximal connector 30, para [0061]; fluid delivery device 60 may be coupled to the housing 14 ... in response to activating 60, fluid may flow distally through housing 14 and the catheter assembly ... 60 provides flushing of the vasculature as the second catheter 12 is advanced, para [0075]).
Regarding claim 14, Burkholz ‘022 and Burkholz ‘248 teach the instrument delivery device of claim 13, and Burkholz ‘022 further teaches wherein the instrument is configured to move between the retracted position and the advanced position responsive to injection of a flushing fluid through the proximal connector (in response to activating fluid delivery device 60, fluid may flow and advanced 12 through the catheter assembly in a distal direction ... 60 may provide flushing of the catheter assembly and vasculature as 12 is advanced, para [0075]).
8. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over in view of US 2023/0226313 (Burkholz) in view of US 2024/0075248 (Burkholz ‘248) as applied above to claim 5, and in further view of US 2023/0137418 (Kelly).
Regarding claim 11, Burkholz and Burkholz ‘248 teach the instrument delivery device of claim 5, but do not specifically teach wherein at least one of the retaining feature and the stiffening component is tipped, to provide a radius or chamfer at an end thereof.
However, Kelly, analogous to catheters, teaches a tip may be subjected to a tipping process to apply a chamfer to a jacket material for a more atraumatic finish (para [0113]).
Accordingly, it would have been obvious to a person having ordinary skill in the art to apply the tipping process to produce a chamfer on a jacket material of Kelly on the stiffening component of Burkholz and Burkholz ‘248, in order to provide an atraumatic finish to the stiffening component and make sure it can not damage the walls of the secondary lumen.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Burkholz and Burkholz ‘248, providing it with a chamfer to a jacket material for a more atraumatic finish as taught by Kelly, motivated by the benefit of an atraumatic finish to the stiffening component ensuring it cannot damage the walls of the secondary lumen, having a predictable outcome absent a teaching of an unexpected result. See KSR International Co. v. Teleflex Inc. et al., 550 U.S. 2007 at 13, lines 22-25 which states, “When a work is available in one field of endeavor, design incentives ...can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES N SMALLEY whose telephone number is (571)272-4547. The examiner can normally be reached M-F 9:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nathan Jenness can be reached at (571) 270-5055. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES N SMALLEY/Examiner, Art Unit 3733
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