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 .
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.
Claims 8 and 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.
Claim 8 recites “a distal end of the another extension tube is integrated with the side port, wherein a proximal end of the other extension tube is integrated with a Y-adapter.” The claim introduces “another extension tube,” but later uses “the other extension tube.” The claim should consistently recite “the another extension tube” or, preferably, “the additional extension tube,” if the same structure is intended. As written, the claim does not distinctly identify whether the distal-end and proximal-end limitations concern the same tube.
Claim 16 recites “the hemoshield device,” while claim 13 introduces “an arterial hemoshield device.” This appears to be a terminology-shortening issue. The claim should read “the arterial hemoshield device” if the same device is intended.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (US2021/0186394A1; hereinafter “Ma”) in view of Cash (US2014/0296745A1) and Ma et al. (US2022/0110562A1; hereinafter “Ciciliano”).
Independent claim 1 recites an arterial catheter system with a catheter adapter, arterial catheter, needle hub and introducer needle, an arterial hemoshield device coupled to the catheter assembly, a fluid pathway, and a first fluidic resistance in a portion of that pathway that is greater than a second fluidic resistance distal to that portion.
In relation to independent claim 1, this claim has been rejected in the following manner:
A catheter assembly having a catheter adapter, catheter, needle hub, and introducer needle.
Ma discloses: “In some embodiments, the catheter system may include a catheter assembly 37, which may include a catheter adapter 39 and a catheter 40. In some embodiments, the catheter 40 may be secured within the catheter adapter 39 and may extend distally from the catheter adapter 39.” (Ma ¶ [0073].) Ma further discloses: “In some embodiments, an introducer needle 45 may extend from a needle shield through the catheter 40.” (Ma ¶ [0073].) To the extent Ma does not expressly use the term “needle hub,” Ciciliano fills that gap by disclosing: “In some embodiments, the needle assembly 54 may include a needle hub 56 and an introducer needle 58 secured within the needle hub 56.” (Ciciliano ¶ [0037].)
An arterial catheter system.
Ma does not expressly disclose that its catheter system is arterial. Cash fills this gap by disclosing: “The MVBTD 20 is designed to be inserted through a split-septum T-connector 27 into the base of an arterial catheter hub 28.” (Cash ¶ [0032].) Cash further discloses: “This allows for blood to flow into the micro bore transfer tube 21 directly from the indwelling arterial catheter 29.” (Cash ¶ [0032].)
A blood-collection/hemoshield device coupled to the catheter assembly, and a fluid pathway through the system.
Ma discloses: “In some embodiments, the extension set may be configured to couple to a catheter assembly and may be referred to as a catheter extension set.” (Ma ¶ [0012].) Ma also discloses: “In some embodiments, the fluid pathway of the catheter system may include one or more of the following: the catheter 40, the catheter adapter 39, the other extension tube 46, the fourth luer adapter 50, the first luer adapter 14, the extension tube 32, the third luer adapter 34, the second luer adapter 24, and the blood collection device 18.” (Ma ¶ [0076].) To the extent Ma does not expressly call the device an “arterial hemoshield device,” Ciciliano discloses a catheter-coupled flow-restrictor device: “In some embodiments, a blood collection system may include a catheter assembly, which may include a catheter adapter and a catheter extending distally from the catheter adapter.” (Ciciliano ¶ [0008].) Ciciliano further discloses: “In some embodiments, the blood collection device may include a flow restrictor, which may include a distal end and a proximal end.” (Ciciliano ¶ [0008].)
A first resistance in one portion greater than a second resistance in another portion.
Ma discloses: “In some embodiments, a flow resistance of the first extension tube 58 may be greater than a flow resistance of the second extension tube 60.” (Ma ¶ [0091].) Ma does not expressly disclose the claimed arterial context or expressly locate the lower-resistance portion distal to the first portion in a serial blood-draw pathway. Cash supplies the arterial catheter context quoted above, and Ciciliano supplies a serial catheter/adapter/extension-tube/flow-restrictor pathway: “In some embodiments, in response to insertion of the catheter 50 into the vasculature, blood may flow proximally through a fluid pathway of the catheter assembly 46, which may include one or more of the following: the catheter 50, the catheter adapter 48, the extension tube 52, an adapter 62, the flow restrictor, and the syringe 12.” (Ciciliano ¶ [0039].)
Motivation to combine. A person of ordinary skill in the art would have been motivated to use Ma’s expressly disclosed differing flow-resistance extension-tube arrangement in Cash’s arterial-catheter sampling environment and to use Ciciliano’s catheter-coupled flow-restrictor placement. The stated teachings address blood collection, flow resistance, and hemolysis in the same technical field: Ma teaches that the extension set may “lower a flow rate of blood” for “hemolysis management” (Ma ¶ [0076]), and Ciciliano teaches that the flow restrictor “may limit a maximum blood collection rate” and thereby “reduce hemolysis” (Ciciliano ¶ [0029]). The combination would predictably implement the known resistance-control arrangement in an arterial blood-draw pathway.
In relation to claim 2, this claim depends from claim 1 and further recites a distal luer-adapter end, a proximal blood-collection-device end, and an extension tube between those ends. Claim 2 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
A distal end comprising a luer adapter; a proximal end comprising a blood collection device; and an extension tube extending therebetween.
Ma discloses: “In some embodiments, the extension set may include a distal end, which may include a luer adapter configured to couple to a catheter adapter or another suitable vascular access device.” (Ma ¶ [0012].) Ma further discloses: “In some embodiments, the extension set may include a proximal end, which may include a blood collection device.” (Ma ¶ [0012].) Ma further discloses: “In some embodiments, the extension set may include an extension tube, which may extend between the distal end of the extension set and the proximal end of the extension set.” (Ma ¶ [0013].) The portion-of-pathway requirement is addressed by Ma’s statement that “the extension set 10 may act as a flow resistor in a fluid pathway of a catheter system.” (Ma ¶ [0073].)
Motivation to combine. Ma already teaches the claimed luer-to-blood-collection-device extension configuration within the same flow-resistance blood-collection system relied on for claim 1. Incorporating that expressly disclosed arrangement into the claim-1 combination would have been a predictable use of Ma’s stated extension-set architecture.
In relation to claim 3, this claim depends from claim 2 and further recites an extension tube whose distal end is integrated with the luer adapter and whose proximal end is integrated with the blood collection device. Claim 3 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 2 is incorporated herein.
Distal extension-tube end integrated with the luer adapter and proximal extension-tube end integrated with the blood collection device.
Ma discloses: “In some embodiments, the distal end of the extension tube may be integrated with the first luer adapter.” (Ma ¶ [0014].) Ma further discloses: “In other embodiments, the proximal end of the extension tube may be integrated with the blood collection device.” (Ma ¶ [0014].)
Motivation to combine. Ma expressly presents the claimed integrations as alternatives within the same catheter extension set. A person of ordinary skill would have been motivated to use Ma’s disclosed integrations when implementing Ma’s own luer-to-blood-collection-device extension-tube arrangement.
In relation to claim 4, this claim depends from claim 2 and further recites first, second, and third luer adapters, with the extension tube integrated between the first and third luer adapters. Claim 4 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 2 is incorporated herein.
First, second, and third luer-adapter arrangement.
Ma discloses: “In some embodiments, the luer adapter may be a first luer adapter. In some embodiments, the blood collection device may include a second luer adapter. In some embodiments, the extension set may include a third luer adapter, which may be coupled to the second luer adapter.” (Ma ¶ [0014].)
Extension tube integrated with the first and third luer adapters.
Ma discloses: “In some embodiments, the distal end of the extension tube may be integrated with the first luer adapter. In some embodiments, the proximal end of the extension tube may be integrated with the third luer adapter.” (Ma ¶ [0014].)
Motivation to combine. Ma itself teaches the specified first/second/third luer-adapter arrangement as part of the extension set. A person of ordinary skill would have used the stated adapter configuration to provide the detachable connection described by Ma without changing the intended blood-collection function.
In relation to claim 5, this claim depends from claim 2 and recites a geometric-factor comparison. Claim 5 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 2 is incorporated herein.
Geometric factors for different fluid-pathway portions.
Ma discloses: “In some embodiments, the extension tube 32 may have multiple sections with lengths (L1, L2, L3) and inner diameters of (D1, D2, D3), the geometric factor is then:” followed by the stated multi-section relationship. (Ma ¶ [0082].) Ma further discloses: “In some embodiments, the first extension tube 58 may be longer than the second extension tube 60.” (Ma ¶ [0091].) Ma also discloses: “In some embodiments, an inner diameter of the first extension tube 58 may be less than an inner diameter of the second extension tube 60.” (Ma ¶ [0091].) To the extent Ma does not expressly use the malformed “Gf” expression, Ciciliano fills the geometric-factor teaching by disclosing: “Since u is the viscosity of the fluid and not part of the flow restrictor geometry, a geometric factor Gf is defined.” (Ciciliano ¶ [0030].)
Motivation to combine. A person of ordinary skill would have been motivated to apply Ciciliano’s stated geometric-factor formulation to Ma’s disclosed sections having different lengths and diameters. Both references identify length and inner diameter as resistance-related flow-pathway design parameters, and the modification would have been a routine parameterization of Ma’s known resistance-control system.
In relation to claim 6, this claim depends from claim 2 and recites that the extension tube has no more than one lumen extending therethrough. Claim 6 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 2 is incorporated herein.
no more than one lumen extending therethrough.
Ma expressly describes “a single multi-lumen extension tube” (Ma ¶ [0090]), while Wang’s cited embodiments also use first and second lumens.
Motivation to combine. In view of the demonstrated conventionality of single-lumen and multiple-lumen extension tube designs, their implementation in the invention would have been considered obvious alternative in the design of the catheter system.
Claims 7, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (US2021/0186394A1; hereinafter “Ma”) in view of Cash (US2014/0296745A1) and Ma et al. (US2022/0110562A1; hereinafter “Ciciliano”), as discussed above, and in further view of Ma et al. (US2021/0228125A1; hereinafter “Wang”).
In relation to claim 7, this claim depends from claim 1 and recites a compact connector comprising a spiral tube, with the relevant pathway portion disposed in the spiral tube. Claim 6 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
Connector coupled to the catheter system.
Ma discloses: “In some embodiments, the adapter 122 may include a Y-adapter, a T-adapter, or another suitable adapter.” (Ma ¶ [0118].) Ma does not expressly disclose a spiral tube in that adapter.
Spiral tube in the fluid pathway.
Wang fills the spiral-path gap by disclosing: “For example, in some embodiments a second extension tube 450b of catheter assembly 400 may include a non-linear portion such as a spiral, a coil shape, an S-shape, or another suitable non-linear shape.” (Wang ¶ [0038].) Wang further discloses: “The non-linear portion may facilitate increased flow resistance within the catheter assembly to distribute the pressure differential and thereby reduce shear stress experienced by red blood cells.” (Wang ¶ [0038].)
Motivation to combine. A person of ordinary skill would have been motivated to place Wang’s expressly disclosed spiral/non-linear portion in Ma’s adapter-connected blood-collection pathway because both references teach catheter blood-draw systems using altered flow resistance to address blood-cell shear. The resulting connector form would implement Wang’s stated increased-flow-resistance function in Ma’s known extension-set architecture, while Cash supplies the arterial sampling setting.
In relation to claim 9, this claim depends from claim 7 and recites a geometric-factor comparison. Claim 9 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 7 is incorporated herein.
Geometric-factor comparison of pathway portions.
Ma discloses multiple path sections having stated lengths and inner diameters and a geometric factor (Ma ¶ [0082]), and Ma discloses a first extension tube with greater flow resistance than a second extension tube (Ma ¶ [0091]). Wang supplies the spiral/non-linear tube (Wang ¶ [0038]). Ciciliano supplies the expressed geometric-factor terminology: “Since u is the viscosity of the fluid and not part of the flow restrictor geometry, a geometric factor Gf is defined.” (Ciciliano ¶ [0030].)
Motivation to combine. A person of ordinary skill would have been motivated to apply the known L/D geometric-factor analysis to Wang’s spiral portion and Ma’s multiple-resistance extension-tube arrangement because all three teachings concern geometric control of fluid resistance in catheter blood collection.
In relation to claim 10, this claim depends from claim 7 and recites that the spiral tube has no more than one lumen extending therethrough. Claim 10 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 7 is incorporated herein.
Spiral tube has no more than one lumen extending therethrough.
As discussed above, Wang discloses a spiral/non-linear “second extension tube” (Wang ¶ [0038]).
Motivation to combine. In view of the demonstrated conventionality of single-lumen and multiple-lumen tube designs, their implementation in the invention would have been considered obvious alternative in the design of the catheter system.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (US2021/0186394A1; hereinafter “Ma”) in view of Cash (US2014/0296745A1), Ma et al. (US2022/0110562A1; hereinafter “Ciciliano”) and Ma et al. (US2021/0228125A1; hereinafter “Wang”), as discussed above, and in further view of Burkholz et al. (US2019/0021640A1; hereinafter “Burkholz”).
In relation to claim 8, this claim depends from claim 7 and further recites a side port, another extension tube, a Y-adapter, and coupling of the compact connector to the Y-adapter. Claim 8 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 7 is incorporated herein.
Side port and another extension tube.
Ma discloses: “In further detail, in some embodiments, another extension tube 46 may extend from a side port 48 [of] the catheter adapter 39.” (Ma ¶ [0074].) Ma further discloses: “In some embodiments, the first extension tube 58 and/or the second extension tube 60 (see, for example, FIGS. 4–9) may be integrated into the side port 48.” (Ma ¶ [0119].)
Y-adapter connection.
Ma discloses: “In some embodiments, the adapter 122 may include a Y-adapter, a T-adapter, or another suitable adapter.” (Ma ¶ [0118].) Burkholz independently discloses: “In some embodiments, the coupler element 32 may include a y-adapter, a single port, or dual ports.” (Burkholz ¶ [0049].) To the extent the primary combination does not expressly identify the claimed integration wording, Ma supplies the closely aligned teaching: “In some embodiments, the distal end of the first extension tube 58 or the distal end of the extension tube 32 may be integrated with the adapter 122 or the catheter adapter 39.” (Ma ¶ [0118].)
Motivation to combine. A person of ordinary skill would have been motivated to use Ma’s disclosed side-port extension and Y-adapter arrangement with the claim 7 spiral-resistance pathway to provide a selectable blood-collection connection. Ma and Burkholz each identify side ports, extension tubes, and Y-adapters in catheter systems, combining their compatible connector teachings would have been a predictable configuration choice.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (US2021/0186394A1; hereinafter “Ma”) in view of Cash (US2014/0296745A1) and Ma et al. (US2022/0110562A1; hereinafter “Ciciliano”), as discussed above, and in further view of Ma et al. (US2022/0047195A1; hereinafter “MA 195”).
In relation to claim 11, this claim depends from claim 1 and recites a female luer adapter, a blood collection device having a male luer adapter and distal opening, a cannula, a sharp proximal tip, an elongated neck, and a pathway through the sharp proximal tip. Claim 11 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
Female luer adapter coupled to the catheter assembly.
Ma ’195 discloses: “In some embodiments, the peripheral intravenous catheter system may include a peripheral intravenous catheter, and a female luer adapter coupled to the peripheral intravenous catheter.” (Ma ’195 ¶ [0009].) Ma ’195 does not expressly identify an arterial catheter. Cash fills the arterial-system context, as quoted above for claim 1.
Male luer adapter, distal opening, cannula, sharp proximal tip, elongated neck, and fluid pathway.
Ma ’195 discloses: “In some embodiments, the distal end of the blood collection device may include a male luer adapter, which may be coupled to the female luer adapter.” (Ma ’195 ¶ [0010].) Ma ’195 further discloses: “In some embodiments, the male luer adapter may include a distal opening.” (Ma ’195 ¶ [0010].) Ma ’195 further discloses: “In some embodiments, the blood collection device may include a cannula in fluid communication with the male luer adapter. In some embodiments, the cannula may include a distal end and a sharp proximal tip.” (Ma ’195 ¶ [0010].) Ma ’195 further discloses: “In some embodiments, the blood collection device may include an elongated neck disposed between the male luer adapter and the sharp proximal tip.” (Ma ’195 ¶ [0010].) Ma ’195 further discloses: “In some embodiments, the blood collection device may include a fluid pathway extending from the distal opening through the sharp proximal tip.” (Ma ’195 ¶ [0010].)
Motivation to combine. A person of ordinary skill would have been motivated to use Ma ’195’s expressly disclosed luer/cannula blood-collection-device structure with the claim1 catheter extension and resistance system. Both references are directed to catheter blood collection and hemolysis reduction; Ma ’195 states that the system “may reduce a risk of mechanical hemolysis during blood collection” (Ma ’195 ¶ [0009]).
In relation to claim 12, this claim depends from claim 11 and recites that geometric factor “Gf” is different to geometric factor “Gf” in another portion of the fluid pathway. Claim 12 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
Geometric factors for different fluid-pathway portions.
Ma discloses: “In some embodiments, the extension tube 32 may have multiple sections with lengths (L1, L2, L3) and inner diameters of (D1, D2, D3), the geometric factor is then:” followed by the stated multi-section relationship. (Ma ¶ [0082].) Ma further discloses: “In some embodiments, the first extension tube 58 may be longer than the second extension tube 60.” (Ma ¶ [0091].) Ma also discloses: “In some embodiments, an inner diameter of the first extension tube 58 may be less than an inner diameter of the second extension tube 60.” (Ma ¶ [0091].) To the extent Ma does not expressly use the malformed “Gf” expression, Ciciliano fills the geometric-factor teaching by disclosing: “Since u is the viscosity of the fluid and not part of the flow restrictor geometry, a geometric factor Gf is defined.” (Ciciliano ¶ [0030].)
Motivation to combine. A person of ordinary skill would have been motivated to apply Ciciliano’s stated geometric-factor formulation to Ma’s disclosed sections having different lengths and diameters. Both references identify length and inner diameter as resistance-related flow-pathway design parameters, and the modification would have been a routine parameterization of Ma’s known resistance-control system.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Cash (US2014/0296745A1) in view of Ma et al. (US2021/0186394A1; hereinafter “Ma”) and Ma et al. (US2022/0110562A1; hereinafter “Ciciliano”).
In relation to independent claim 13, this claim recites a method of blood collection including inserting an arterial catheter of the system into an artery and collecting arterial blood in a blood collection device through the higher-resistance portion. Claim 13 has been rejected in the following manner:
Arterial blood collection through an arterial catheter.
Cash discloses: “The device can be used for a Peripheral Arterial Line (PAL) catheter blood draw.” (Cash ¶ [0033].) Cash further discloses: “the mini pinch clamp for the sample side 34 is released allowing clean blood to flow up the micro bore collection tube 21 and into the syringe.” (Cash ¶ [0033].) Cash does not expressly disclose the claim’s higher-resistance flow portion.
Higher-resistance portion in the collection path.
Ma fills the different-resistance gap by disclosing: “In some embodiments, a flow resistance of the first extension tube 58 may be greater than a flow resistance of the second extension tube 60.” (Ma ¶ [0091].) Ciciliano fills the catheter/flow-restrictor implementation gap by disclosing: “In some embodiments, the flow restrictor 24 may provide hemolysis protection.” (Ciciliano ¶ [0029].) Ciciliano further discloses: “the flow restrictor 24 may limit a maximum blood collection rate, which in turn may limit a maximum shear stress during blood collection and reduce hemolysis.” (Ciciliano ¶ [0029].)
Motivation to combine. A person of ordinary skill would have been motivated to use Ma’s and Ciciliano’s resistance-control teachings in Cash’s arterial blood-draw method to control collection flow and reduce shear-related blood damage. The references expressly focus on blood collection, resistance, and reduced hemolysis, providing a direct technical reason for the combination.
In relation to claim 14, this claim depends from claim 13 and further recites the luer-adapter/blood-collection-device/extension-tube configuration. Claim 14 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 13 is incorporated herein.
Distal luer adapter, proximal blood collection device, and extension tube.
Ma discloses the luer-adapter distal end and blood-collection-device proximal end (Ma ¶ [0012]) and further discloses the extension tube extending between the distal and proximal ends (Ma ¶ [0013]).
Motivation to combine. The same motivation stated for claim 13 applies. Ma’s stated extension-set configuration would provide the known luer-to-collection-device path for Cash’s arterial blood-draw procedure.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Cash (US2014/0296745A1) in view of Ma et al. (US2021/0186394A1; hereinafter “Ma”) and Ma et al. (US2022/0110562A1; hereinafter “Ciciliano”), as discussed above, and in further view of Ma et al. (US2021/0228125A1; hereinafter “Wang”).
In relation to claim 15, this claim depends from claim 13 and further recites a compact connector comprising a spiral tube. Claim 15 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 13 is incorporated herein.
Spiral tube/compact connector arrangement.
Ma teaches an adapter that “may include a Y-adapter, a T-adapter, or another suitable adapter” (Ma ¶ [0118]). Wang supplies the absent spiral-path teaching: “a second extension tube 450b of catheter assembly 400 may include a non-linear portion such as a spiral, a coil shape, an S-shape, or another suitable non-linear shape.” (Wang ¶ [0038].) Wang further teaches that the non-linear portion “may facilitate increased flow resistance within the catheter assembly.” (Wang ¶ [0038].)
Motivation to combine. A person of ordinary skill would have been motivated to use Wang’s disclosed spiral-path resistance feature in claim13 arterial collection method because it addresses the same flow-resistance and shear-stress concern identified in Ma and Ciciliano.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Cash (US2014/0296745A1) in view of Ma et al. (US2021/0186394A1; hereinafter “Ma”) and Ma et al. (US2022/0110562A1; hereinafter “Ciciliano”), as discussed above, and in further view of Ma et al. (US2022/0047195A1; hereinafter “MA 195”).
In relation to claim 16, this claim depends from claim 13 and further recites the female-luer, male-luer, cannula, elongated-neck, and fluid-pathway structure. Claim 16 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 13 is incorporated herein.
Female luer, male luer, cannula, elongated neck, and pathway.
Ma ’195 discloses a female luer adapter coupled to a peripheral intravenous catheter (Ma ’195 ¶ [0009]) and the following exact structure: “the distal end of the blood collection device may include a male luer adapter, which may be coupled to the female luer adapter”; “the male luer adapter may include a distal opening”; “the blood collection device may include a cannula in fluid communication with the male luer adapter”; “the cannula may include a distal end and a sharp proximal tip”; “the blood collection device may include an elongated neck disposed between the male luer adapter and the sharp proximal tip”; and “the blood collection device may include a fluid pathway extending from the distal opening through the sharp proximal tip.” (Ma ’195 ¶ [0010].) Cash fills the arterial collection environment gap, as quoted in claim 13.
Motivation to combine. A person of ordinary skill would have been motivated to use Ma ’195’s blood-collection-device geometry in Cash’s arterial method because Ma ’195 expressly teaches that the geometry is for a catheter blood-collection system and may reduce mechanical hemolysis (Ma ’195 ¶ [0009]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (US2022/0110562A1; hereinafter “Ciciliano”) in view of Ma et al. (US2021/0186394A1; hereinafter “Ma”), as discussed above, and in further view of Cash (US2014/0296745A1).
In relation to independent claim 17, this claim recites a method of manufacturing an arterial catheter system by coupling a catheter assembly to a needle assembly, coupling an arterial hemoshield device in fluid communication, and selecting a portion length L and inner diameter D to make a first resistance greater than a second resistance distal to that portion. Independent claim 17 has been rejected in the following manner:
Catheter assembly coupled to a needle assembly.
Ciciliano discloses: “In some embodiments, a needle assembly 54 may be coupled to the catheter assembly 46.” (Ciciliano ¶ [0037].) Ciciliano further discloses: “In some embodiments, the needle assembly 54 may include a needle hub 56 and an introducer needle 58 secured within the needle hub 56.” (Ciciliano ¶ [0037].)
Flow-restrictor device coupled to the catheter assembly and in a fluid pathway.
Ciciliano discloses: “In some embodiments, a flow restrictor, such as the flow restrictor 24 (see, for example, FIGS. 1A–1B) or the flow restrictor 38 (see, for example, FIGS. 2A–2B), may be coupled to a catheter assembly 46.” (Ciciliano ¶ [0036].) Ciciliano further discloses the fluid pathway that includes “the catheter 50, the catheter adapter 48, the extension tube 52, an adapter 62, the flow restrictor, and the syringe 12.” (Ciciliano ¶ [0039].) Ciciliano does not expressly identify an arterial catheter system. Cash fills this gap by teaching an “arterial catheter hub” and “indwelling arterial catheter” (Cash ¶ [0032]).
Selecting L and D for resistance control.
Ciciliano discloses: “Fluid flow in a flow restrictor with a tubular fluid pathway therethrough can be analyzed using Poiseuille’s equation.” (Ciciliano ¶ [0030].) Ciciliano further discloses that “D and L are the inner diameter and length, respectively, of the fluid pathway 36 through the flow restrictor.” (Ciciliano ¶ [0030].) Ciciliano does not expressly state the claimed comparison between a first resistance in a selected portion and a second resistance in a distal portion. Ma fills that gap by disclosing: “In some embodiments, a flow resistance of the first extension tube 58 may be greater than a flow resistance of the second extension tube 60.” (Ma ¶ [0091].)
Motivation to combine. A person of ordinary skill would have been motivated to select Ciciliano’s stated L and D flow-pathway parameters to implement Ma’s expressly disclosed differing-resistance arrangement in an arterial catheter system taught by Cash. Ciciliano directly ties the flow restrictor to limiting collection rate and reducing hemolysis (Ciciliano ¶ [0029]); Ma directly teaches different extension-tube resistances (Ma ¶ [0091]). The combination therefore supplies a known, technically compatible basis for choosing geometry to obtain a resistance-controlled blood-draw pathway.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Respectfully submitted,
/MANUEL A MENDEZ/
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