DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 09 February 2026 has been entered. Claim(s) 1-14 and 16-21 are pending in the application. Applicant’s amendments to the claims have overcome each and every objection to the claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-14 and 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20210228127 A1) in view of Ma (US 20220047195 A1), further in view of Piferi (US 20210100977 A1).
Regarding claim 1, Burkholz teaches a flow restriction device (10), comprising:
a male luer connector portion defining a first lumen (Distal connector 14; paragraph 0029-- the distal connector 14 may include a male luer threaded connector);
a female luer connector portion defining a second lumen (proximal connector 18; paragraph 0033-- the proximal connector 18 may include a female luer connector or another suitable connector); and
a tube (Nonlinear portion 22 which extends through tube 28), defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Paragraph 0036-- As an example, the length L may extend from a distal end 24 of the fluid pathway 20 to a proximal end 26 of the fluid pathway 20; Fig. 2B shows the fluid pathway 20 extending from a lumen of the first connector portion, through the middle connector portion, to the second connector portion; Abstract—the fluid pathway includes a non-linear portion).
However, Burkholz does not disclose the third lumen having a diameter about 0.02 inches.
Ma, in the same field of endeavor of a flow restriction device (Abstract), teaches a device having a male luer connector portion defining a first lumen (Male connector 26; paragraph 0030-0031); a female luer connector portion defining a second lumen (Female connector 46; paragraph 0035); and a tube defining a third lumen (Elongated neck 35 having fluid pathway 36 therethrough; paragraph 0032-0035), wherein the third lumen is in fluid communication with the first lumen and the second lumen (Elongated neck 35 connects the blood collection device 20 and the catheter 54 as shown in Fig. 3A-3B; paragraph 0010, 0035-0036), and the third lumen having a diameter about 0.02 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 0.017in D show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art).
It would have been obvious to one having ordinary skill in the art to modify the device of Burkholz to have the fluid path dimensions disclosed by Ma in order to predictably improve the ability of the device to maintain blood flow for collection while reducing hemolysis by reducing shear stress which may be done by providing the given dimensions in a fluid pathway (see Burkholz, paragraph 0035).
However, Burkholz fails to explicitly disclose wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion.
Piferi, in the same field of endeavor of a device for transferring fluid including an extension tube, teaches a device including a male luer connector portion defining a first lumen (Connector 502), a female luer connector portion defining a second lumen (Connector 505), and an extension tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Tube 510; paragraphs 0038, 0081-0085, 0091-- an extension tube assembly 500 comprising an external support tube 510 and a longitudinally extending inner tube 530 [where the inner tube serves as the third lumen]… The inner tube 230 can be aligned with and couple to the inner tube 30 in the tubular cannula 20 and to the inner tube 530 in the extension tube assembly 500), wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion (Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the tube of Burkholz to be more flexible than the luer connectors as described by Piferi, in order to allow the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 2, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 1. However, Burkholz fails to disclose wherein the third lumen has a length of about 1.3 inches. Ma discloses wherein the third lumen has a length of less than 1 inch, 1.6 inches, or 1.44 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 1.6 or 1.44in L show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art; Figs. 2A-2D, the fluid pathway length is shown by 38, which encompasses the third lumen 35 having the fluid pathway 36 therethrough but additionally includes the lengths of the male luer connector portion and female luer connector portion such that the length of the third lumen must be less than length 38). It is additionally noted that the claimed dimensions of a diameter of about 0.02 inches and a length of about 1.3 inches satisfy the disclosed preferred parameters of Ma of a device of diameter 20 G and D.sup.4/L is equal to or less than 3.1E-07 cubic inches and a device of diameter 22 G having D.sup.4/L is equal to or less than 1.6E-07 cubic inches, where this is determined to be an optimized ratio corresponding to a low risk of hemolysis (Paragraph 0042-- the predetermined value may correspond to a value at which the risk of hemolysis is determined to be low).
It would have been obvious to one having ordinary skill in the art to modify the device of Burkholz to have the fluid path dimensions suggested by Ma in order to predictably improve the ability of the device to maintain blood flow for collection while reducing hemolysis by reducing shear stress which may be done by providing the given dimensions in a fluid pathway (see Burkholz, paragraph 0035), wherein the use of a third lumen length of about 1.3 inches may be selected through routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" and Ma has disclosed that the fluid pathway length may be selected through this process to ensure a low risk of hemolysis. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 3, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 1. Burkholz additionally teaches wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow (Paragraph 0034-0041-- the non-linear portion may facilitate increased flow resistance within the vascular access system to distribute the pressure differential and reduce shear stress experienced by red blood cells… the fluid pathway 20 may include a length L… the fluid pathway 20 may include an inner diameter D…).
Regarding claim 4, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 1. Burkholz additionally teaches wherein the male luer connector portion is configured to be coupled to a catheter hub (Paragraph 0009, 0029-0032-- the adapter may include a distal end, which may be configured to couple to a catheter assembly… the adapter 10 may include a distal end 12, which may include a distal connector 14 configured to couple to the catheter assembly… the catheter assembly may include a catheter hub, which may include a distal end, a proximal end, and a lumen extending through the distal end and the proximal end).
Regarding claim 5, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 1. Burkholz additionally teaches wherein the female luer connector portion is configured to couple to a fluid collection device (Paragraph 0033, 0045-0047-- the adapter 10 may include a proximal end 16, which may include a proximal connector 18 configured to couple to a blood collection device; blood collection device 34).
Regarding claim 6, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 1. Burkholz additionally teaches wherein the female luer connector portion defines an extension portion (See Figs. 1A-4B, female luer forms an extension portion off of the tubing).
Regarding claim 7, Burkholz teaches a flow restriction device (10), comprising:
a male luer connector portion defining a first lumen (Distal connector 14; paragraph 0029-- the distal connector 14 may include a male luer threaded connector);
a female luer connector portion defining a second lumen (proximal connector 18; paragraph 0033-- the proximal connector 18 may include a female luer connector or another suitable connector); and
a tube (Nonlinear portion 22 which extends through tube 28), defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Paragraph 0036-- As an example, the length L may extend from a distal end 24 of the fluid pathway 20 to a proximal end 26 of the fluid pathway 20; Fig. 2B shows the fluid pathway 20 extending from a lumen of the first connector portion, through the middle connector portion, to the second connector portion; Abstract—the fluid pathway includes a non-linear portion).
However, Burkholz does not disclose the third lumen having a diameter about 0.02 inches and a length of about 1.3 inches.
Ma, in the same field of endeavor of a flow restriction device (Abstract), teaches a device having a male luer connector portion defining a first lumen (Male connector 26; paragraph 0030-0031); a female luer connector portion defining a second lumen (Female connector 46; paragraph 0035); and a tube defining a third lumen (Elongated neck 35 having fluid pathway 36 therethrough; paragraph 0032-0035), wherein the third lumen is in fluid communication with the first lumen and the second lumen (Elongated neck 35 connects the blood collection device 20 and the catheter 54 as shown in Fig. 3A-3B; paragraph 0010, 0035-0036), and the third lumen having a diameter about 0.02 inches and a length of about 1.3 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 0.017in D with 1.6 or 1.44in L show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art Figs. 2A-2D, the fluid pathway length is shown by 38, which encompasses the third lumen 35 having the fluid pathway 36 therethrough but additionally includes the lengths of the male luer connector portion and female luer connector portion such that the length of the third lumen must be less than length 38). It is additionally noted that the claimed dimensions of a diameter of about 0.02 inches and a length of about 1.3 inches satisfy the disclosed preferred parameters of Ma of a device of diameter 20 G and D.sup.4/L is equal to or less than 3.1E-07 cubic inches and a device of diameter 22 G having D.sup.4/L is equal to or less than 1.6E-07 cubic inches, where this is determined to be an optimized ratio corresponding to a low risk of hemolysis (Paragraph 0042-- the predetermined value may correspond to a value at which the risk of hemolysis is determined to be low).
It would have been obvious to one having ordinary skill in the art to modify the device of Burkholz to have the fluid path dimensions suggested by Ma in order to predictably improve the ability of the device to maintain blood flow for collection while reducing hemolysis by reducing shear stress which may be done by providing the given dimensions in a fluid pathway (see Burkholz, paragraph 0035), wherein the use of a third lumen length of about 1.3 inches may be selected through routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" and Ma has disclosed that the fluid pathway length may be selected through this process to ensure a low risk of hemolysis. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
However, Burkholz fails to explicitly disclose wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion.
Piferi, in the same field of endeavor of a device for transferring fluid including an extension tube, teaches a device including a male luer connector portion defining a first lumen (Connector 502), a female luer connector portion defining a second lumen (Connector 505), and an extension tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Tube 510; paragraphs 0038, 0081-0085, 0091-- an extension tube assembly 500 comprising an external support tube 510 and a longitudinally extending inner tube 530 [where the inner tube serves as the third lumen]… The inner tube 230 can be aligned with and couple to the inner tube 30 in the tubular cannula 20 and to the inner tube 530 in the extension tube assembly 500), wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion (Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the tube of Burkholz to be more flexible than the luer connectors as described by Piferi, in order to allow the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 8, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 7. Burkholz additionally teaches wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow (Paragraph 0034-0041-- the non-linear portion may facilitate increased flow resistance within the vascular access system to distribute the pressure differential and reduce shear stress experienced by red blood cells… the fluid pathway 20 may include a length L… the fluid pathway 20 may include an inner diameter D…).
Regarding claim 9, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 7. Burkholz additionally teaches wherein the male luer connector portion is configured to be coupled to a catheter hub (Paragraph 0009, 0029-0032-- the adapter may include a distal end, which may be configured to couple to a catheter assembly… the adapter 10 may include a distal end 12, which may include a distal connector 14 configured to couple to the catheter assembly… the catheter assembly may include a catheter hub, which may include a distal end, a proximal end, and a lumen extending through the distal end and the proximal end).
Regarding claim 10, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 7. Burkholz additionally teaches wherein the female luer connector portion is configured to be coupled to a fluid collection device (Paragraph 0033, 0045-0047-- the adapter 10 may include a proximal end 16, which may include a proximal connector 18 configured to couple to a blood collection device; blood collection device 34).
Regarding claim 11, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 7. Burkholz additionally teaches wherein the female luer connector portion defines an extension portion (See Figs. 1A-4B, female luer forms an extension portion off of the tubing).
Regarding claim 12, Burkholz teaches a peripheral intravenous catheter assembly configured to limit hemolysis during drawing of blood from a patient (Abstract, paragraph 0002-0004, 0009, 0029-0032--- the adapter 10 may be configured to reduce a likelihood of hemolysis during blood collection using a vascular access device. In some embodiments, the vascular access device may include a catheter assembly… In some embodiments, the catheter may include a peripheral intravenous catheter (PIVC)), comprising:
a catheter hub having a proximal end and a distal end (Paragraph 0009, 0029-0032-- the adapter may include a distal end, which may be configured to couple to a catheter assembly… the adapter 10 may include a distal end 12, which may include a distal connector 14 configured to couple to the catheter assembly… the catheter assembly may include a catheter hub, which may include a distal end, a proximal end, and a lumen extending through the distal end and the proximal end);
a fluid collection device (Paragraph 0033, 0045-0047-- the adapter 10 may include a proximal end 16, which may include a proximal connector 18 configured to couple to a blood collection device; blood collection device 34); and
a flow restriction device (10), comprising:
a male luer connector portion defining a first lumen (Distal connector 14; paragraph 0029-- the distal connector 14 may include a male luer threaded connector);
a female luer connector portion defining a second lumen (proximal connector 18; paragraph 0033-- the proximal connector 18 may include a female luer connector or another suitable connector); and
a tube (Nonlinear portion 22 which extends through tube 28), defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Paragraph 0036-- As an example, the length L may extend from a distal end 24 of the fluid pathway 20 to a proximal end 26 of the fluid pathway 20; Fig. 2B shows the fluid pathway 20 extending from a lumen of the first connector portion, through the middle connector portion, to the second connector portion; Abstract—the fluid pathway includes a non-linear portion).
However, Burkholz does not disclose the third lumen having a diameter about 0.02 inches.
Ma, in the same field of endeavor of a flow restriction device (Abstract), teaches a device having a male luer connector portion defining a first lumen (Male connector 26; paragraph 0030-0031); a female luer connector portion defining a second lumen (Female connector 46; paragraph 0035); and a tube defining a third lumen (Elongated neck 35 having fluid pathway 36 therethrough; paragraph 0032-0035), wherein the third lumen is in fluid communication with the first lumen and the second lumen (Elongated neck 35 connects the blood collection device 20 and the catheter 54 as shown in Fig. 3A-3B; paragraph 0010, 0035-0036), and the third lumen having a diameter about 0.02 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 0.017in D show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art).
It would have been obvious to one having ordinary skill in the art to modify the device of Burkholz to have the fluid path dimensions disclosed by Ma in order to predictably improve the ability of the device to maintain blood flow for collection while reducing hemolysis by reducing shear stress which may be done by providing the given dimensions in a fluid pathway (see Burkholz, paragraph 0035).
However, Burkholz fails to explicitly disclose wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion.
Piferi, in the same field of endeavor of a device for transferring fluid including an extension tube, teaches a device including a male luer connector portion defining a first lumen (Connector 502), a female luer connector portion defining a second lumen (Connector 505), and an extension tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Tube 510; paragraphs 0038, 0081-0085, 0091-- an extension tube assembly 500 comprising an external support tube 510 and a longitudinally extending inner tube 530 [where the inner tube serves as the third lumen]… The inner tube 230 can be aligned with and couple to the inner tube 30 in the tubular cannula 20 and to the inner tube 530 in the extension tube assembly 500), wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion (Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the tube of Burkholz to be more flexible than the luer connectors as described by Piferi, in order to allow the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 13, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 12. However, Burkholz fails to disclose wherein the third lumen has a length of about 1.3 inches. Ma discloses wherein the third lumen has a length of about 1.3 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 1.6 or 1.44in L show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art Figs. 2A-2D, the fluid pathway length is shown by 38, which encompasses the third lumen 35 having the fluid pathway 36 therethrough but additionally includes the lengths of the male luer connector portion and female luer connector portion such that the length of the third lumen must be less than length 38). It is additionally noted that the claimed dimensions of a diameter of about 0.02 inches and a length of about 1.3 inches satisfy the disclosed preferred parameters of Ma of a device of diameter 20 G and D.sup.4/L is equal to or less than 3.1E-07 cubic inches and a device of diameter 22 G having D.sup.4/L is equal to or less than 1.6E-07 cubic inches, where this is determined to be an optimized ratio corresponding to a low risk of hemolysis (Paragraph 0042-- the predetermined value may correspond to a value at which the risk of hemolysis is determined to be low).
It would have been obvious to one having ordinary skill in the art to modify the device of Burkholz to have the fluid path dimensions suggested by Ma in order to predictably improve the ability of the device to maintain blood flow for collection while reducing hemolysis by reducing shear stress which may be done by providing the given dimensions in a fluid pathway (see Burkholz, paragraph 0035), wherein the use of a third lumen length of about 1.3 inches may be selected through routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" and Ma has disclosed that the fluid pathway length may be selected through this process to ensure a low risk of hemolysis. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 12. Burkholz additionally teaches wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow (Paragraph 0034-0041-- the non-linear portion may facilitate increased flow resistance within the vascular access system to distribute the pressure differential and reduce shear stress experienced by red blood cells… the fluid pathway 20 may include a length L… the fluid pathway 20 may include an inner diameter D…).
Regarding claim 16, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 12. Burkholz additionally teaches wherein the female luer connector portion defines an extension portion (See Figs. 1A-4B, female luer forms an extension portion off of the tubing).
Regarding claim 17, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 1. Piferi additionally teaches wherein the male luer connector portion is movable relative to the female luer connector portion (Connector 505 is connected to connector 502 via the tube 510; Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting; paragraph 0076).
It would have been obvious to one having ordinary skill in the art at the time of filing that the modification of Burkholz to utilize a tube more flexible than the luer connectors as described by Piferi would additionally enable the male luer connector portion to be movable relative to the female luer connector portion, thus allowing the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 18, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 1. Burkholz additionally teaches wherein the male luer connector portion is coupled to a first end of the tube and the female luer connector portion is coupled to a second end of the tube (Paragraph 0036-- As an example, the length L may extend from a distal end 24 of the fluid pathway 20 to a proximal end 26 of the fluid pathway 20; Fig. 2B shows the fluid pathway 20 extending from a lumen of the first connector portion, through the middle connector portion, to the second connector portion).
Regarding claim 19, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 1. Burkholz additionally teaches that an inner diameter may vary over the length of the fluid pathway such that the diameter of the third lumen may be smaller than a first diameter of the first lumen and a second diameter of the second lumen (Paragraph 0038-0039; Fig. 3B, 4B, 5).
Regarding claim 20, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 7. Piferi additionally teaches wherein the male luer connector portion is movable relative to the female luer connector portion (Connector 505 is connected to connector 502 via the tube 510; Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting; paragraph 0076).
It would have been obvious to one having ordinary skill in the art at the time of filing that the modification of Burkholz to utilize a tube more flexible than the luer connectors as described by Piferi would additionally enable the male luer connector portion to be movable relative to the female luer connector portion, thus allowing the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 21, the combination of Burkholz, Ma, and Piferi teaches the flow restriction device of claim 12. Burkholz additionally teaches the catheter hub and fluid collection device are positioned at opposite ends of the tube (see distal end 12 and proximal end 16 of the adapter 10).
Piferi additionally teaches wherein an end of the tube is movable relative to the opposite end of the tube (Connector 505 is connected to connector 502 via the tube 510; Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting; paragraph 0076).
It would have been obvious to one having ordinary skill in the art at the time of filing that the modification of Burkholz to utilize a tube more flexible than the luer connectors as described by Piferi would additionally enable the device connected to male luer connector portion to be movable relative to the device connected to the female luer connector portion, thus allowing the assembly to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Claim(s) 1-6, 15, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Burkholz, further in view of Piferi.
Regarding claim 1, Ma teaches a flow restriction device (Abstract-- A blood collection device to reduce hemolysis; extension 50), comprising:
a male luer connector portion defining a first lumen (Male connector 26; paragraph 0030-0031);
a female luer connector portion defining a second lumen (Female connector 46; paragraph 0035); and
a tube defining a third lumen (Elongated neck 35 having fluid pathway 36 therethrough; paragraph 0032-0035), wherein the third lumen is in fluid communication with the first lumen and the second lumen (Elongated neck 35 connects the blood collection device 20 and the catheter 54 as shown in Fig. 3A-3B; paragraph 0010, 0035-0036), and
the third lumen having a diameter about 0.02 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 0.017in D show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art).
However, Ma does not explicitly disclose the tube is flexible. Burkholz, in the same field of endeavor of a flow restriction device for reducing hemolysis, discloses an extension is a flexible tube (Figs. 1A-4B, nonlinear portion 22/tube 28 is a helical tube arranged between the male luer portion 14 and the female luer portion 18; paragraph 0035-- the non-linear portion 22 may form a coil shape, an S-shape, or another suitable shape. As illustrated in FIGS. 1A-1B, in some embodiments, the non-linear portion 22 may include the coil shape, which may include a spiral).
It would have been obvious to one having ordinary skill in the art to modify the device of Ma to have a flexible tube in order to predictably improve the ability of the device to further reduce hemolysis which may be done by providing a nonlinear shape to the tube (see Burkholz, paragraph 0035).
However, the combination fails to explicitly disclose wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion.
Piferi, in the same field of endeavor of a device for transferring fluid including an extension tube, teaches a device including a male luer connector portion defining a first lumen (Connector 502), a female luer connector portion defining a second lumen (Connector 505), and an extension tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Tube 510; paragraphs 0038, 0081-0085, 0091-- an extension tube assembly 500 comprising an external support tube 510 and a longitudinally extending inner tube 530 [where the inner tube serves as the third lumen]… The inner tube 230 can be aligned with and couple to the inner tube 30 in the tubular cannula 20 and to the inner tube 530 in the extension tube assembly 500), wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion (Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the tube of the combination to be more flexible than the luer connectors as described by Piferi, in order to allow the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 2, the combination of Ma, Burkholz, and Piferi teaches the flow restriction device of claim 1. Ma additionally discloses wherein the third lumen has a length of about 1.3 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 1.6 or 1.44in L show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art Figs. 2A-2D, the fluid pathway length is shown by 38, which encompasses the third lumen 35 having the fluid pathway 36 therethrough but additionally includes the lengths of the male luer connector portion and female luer connector portion such that the length of the third lumen must be less than length 38). It is additionally noted that the claimed dimensions of a diameter of about 0.02 inches and a length of about 1.3 inches satisfy the disclosed preferred parameters of Ma of a device of diameter 20 G and D.sup.4/L is equal to or less than 3.1E-07 cubic inches and a device of diameter 22 G having D.sup.4/L is equal to or less than 1.6E-07 cubic inches, where this is determined to be an optimized ratio corresponding to a low risk of hemolysis (Paragraph 0042-- the predetermined value may correspond to a value at which the risk of hemolysis is determined to be low).
Regarding claim 3, the combination of Ma, Burkholz, and Piferi teaches the flow restriction device of claim 1. Ma additionally discloses wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow (Paragraph 0035-- the blood collection device 20 may include an extension 50, which a user may couple to the holder 41 to provide the elongated neck 35 and an increased L, which may decrease the risk of hemolysis; Paragraph 0044-0045; Fig. 4B).
Regarding claim 4, the combination of Ma, Burkholz, and Piferi teaches the flow restriction device of claim 1. Ma additionally teaches wherein the male luer connector portion is configured to be coupled to a catheter hub (catheter adapter 58 which is attached via an extension tube 66 and adapter 56 to the male luer 26; paragraph 0037-0038-- the peripheral intravenous catheter system 52 may include a catheter adapter 58, which may include a distal end 60, a proximal end 62, and a lumen 64 extending through the distal end 60 of the catheter adapter 58 and the proximal end 62 of the catheter adapter 58).
Regarding claim 5, the combination of Ma, Burkholz, and Piferi teaches the flow restriction device of claim 1. Ma additionally teaches wherein the female luer connector portion is configured to couple to a fluid collection device (Blood collection device 20 including holder 42 couples to female luer 46; paragraph 0033-0035).
Regarding claim 6, the combination of Ma, Burkholz, and Piferi teaches the flow restriction device of claim 1. Ma additionally teaches wherein the female luer connector portion defines an extension portion (See Fig. 2D).
Regarding claim 15, Ma teaches the flow restriction device of claim 12. However, Ma fails to disclose the tube is flexible.
Burkholz discloses the tube is flexible (Figs. 1A-4B, nonlinear portion 22/tube 28 is a helical tube arranged between the male luer portion 14 and the female luer portion 18; paragraph 0035-- the non-linear portion 22 may form a coil shape, an S-shape, or another suitable shape. As illustrated in FIGS. 1A-1B, in some embodiments, the non-linear portion 22 may include the coil shape, which may include a spiral).
It would have been obvious to one having ordinary skill in the art to modify the device of Ma to have a flexible tube in order to predictably improve the ability of the device to further reduce hemolysis which may be done by providing a nonlinear shape to the tube (see Burkholz, paragraph 0035).
Regarding claim 17, the combination of Ma, Burkholz, and Piferi teaches the flow restriction device of claim 1. Piferi additionally teaches wherein the male luer connector portion is movable relative to the female luer connector portion (Connector 505 is connected to connector 502 via the tube 510; Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting; paragraph 0076).
It would have been obvious to one having ordinary skill in the art at the time of filing that the modification of Ma to utilize a tube more flexible than the luer connectors as described by Piferi would additionally enable the male luer connector portion to be movable relative to the female luer connector portion, thus allowing the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 18, the combination of Ma, Burkholz, and Piferi teaches the flow restriction device of claim 1. Ma additionally teaches wherein the male luer connector portion is coupled to a first end of the tube and the female luer connector portion is coupled to a second end of the tube (Elongated neck 35 connects the blood collection device 20 and the catheter 54 as shown in Fig. 3A-3B; paragraph 0010, 0035-0036).
Regarding claim 19, the combination of Ma, Burkholz, and Piferi teaches the flow restriction device of claim 1. Burkholz additionally teaches that an inner diameter may vary over the length of the fluid pathway such that the diameter of the third lumen may be smaller than a first diameter of the first lumen and a second diameter of the second lumen (Paragraph 0038-0039). It would have been obvious to one having ordinary skill in the art at the time of filing to further modify the device of Ma to include a change in diameter of the flow path according to Burkholz in order to further modify the fluid resistance of the fluid pathway to predictably improve the hemolysis reduction of the system.
Claim(s) 7-14, 16, and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Piferi.
Regarding claim 7, Ma teaches a flow restriction device (Abstract-- A blood collection device to reduce hemolysis; extension 50), comprising:
a male luer connector portion defining a first lumen (Male connector 26; paragraph 0030-0031);
a female luer connector portion defining a second lumen (Female connector 46; paragraph 0035); and
a tube defining a third lumen (Elongated neck 35 having fluid pathway 36 therethrough; paragraph 0032-0035), wherein the third lumen is in fluid communication with the first lumen and the second lumen (Elongated neck 35 connects the blood collection device 20 and the catheter 54 as shown in Fig. 3A-3B; paragraph 0010, 0035-0036), and
the third lumen having a diameter about 0.02 inches and a length of about 1.3 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 0.017in D with 1.6 or 1.44in L show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art Figs. 2A-2D, the fluid pathway length is shown by 38, which encompasses the third lumen 35 having the fluid pathway 36 therethrough but additionally includes the lengths of the male luer connector portion and female luer connector portion such that the length of the third lumen must be less than length 38). It is additionally noted that the claimed dimensions of a diameter of about 0.02 inches and a length of about 1.3 inches satisfy the disclosed preferred parameters of Ma of a device of diameter 20 G and D.sup.4/L is equal to or less than 3.1E-07 cubic inches and a device of diameter 22 G having D.sup.4/L is equal to or less than 1.6E-07 cubic inches, where this is determined to be an optimized ratio corresponding to a low risk of hemolysis (Paragraph 0042-- the predetermined value may correspond to a value at which the risk of hemolysis is determined to be low).
It would have been obvious to one having ordinary skill in the art to modify the device of Ma to have a third lumen length of about 1.3 inches may be selected through routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" and Ma has disclosed that the fluid pathway length may be selected through this process to ensure a low risk of hemolysis. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
However, Ma fails to explicitly disclose wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion.
Piferi, in the same field of endeavor of a device for transferring fluid including an extension tube, teaches a device including a male luer connector portion defining a first lumen (Connector 502), a female luer connector portion defining a second lumen (Connector 505), and an extension tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Tube 510; paragraphs 0038, 0081-0085, 0091-- an extension tube assembly 500 comprising an external support tube 510 and a longitudinally extending inner tube 530 [where the inner tube serves as the third lumen]… The inner tube 230 can be aligned with and couple to the inner tube 30 in the tubular cannula 20 and to the inner tube 530 in the extension tube assembly 500), wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion (Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the tube of Ma to be more flexible than the luer connectors as described by Piferi, in order to allow the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 8, the combination of Ma and Piferi discloses the flow restriction device of claim 7. Ma additionally discloses wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow (Paragraph 0035-- the blood collection device 20 may include an extension 50, which a user may couple to the holder 41 to provide the elongated neck 35 and an increased L, which may decrease the risk of hemolysis; Paragraph 0044-0045; Fig. 4B).
Regarding claim 9, the combination of Ma and Piferi teaches the flow restriction device of claim 7. Ma additionally teaches wherein the male luer connector portion is configured to be coupled to a catheter hub (catheter adapter 58 which is attached via an extension tube 66 and adapter 56 to the male luer 26; paragraph 0037-0038-- the peripheral intravenous catheter system 52 may include a catheter adapter 58, which may include a distal end 60, a proximal end 62, and a lumen 64 extending through the distal end 60 of the catheter adapter 58 and the proximal end 62 of the catheter adapter 58).
Regarding claim 10, the combination of Ma and Piferi teaches the flow restriction device of claim 7. Ma additionally teaches wherein the female luer connector portion is configured to couple to a fluid collection device (Blood collection device 20 including holder 42 couples to female luer 46; paragraph 0033-0035).
Regarding claim 11, the combination of Ma and Piferi teaches the flow restriction device of claim 7. Ma additionally teaches wherein the female luer connector portion defines an extension portion (See Fig. 2D).
Regarding claim 12, Ma teaches a peripheral intravenous catheter assembly (52) configured to limit hemolysis during drawing of blood from a patient, comprising:
a catheter hub having a proximal end and a distal end (catheter adapter 58; paragraph 0037-- the peripheral intravenous catheter system 52 may include a catheter adapter 58, which may include a distal end 60, a proximal end 62, and a lumen 64 extending through the distal end 60 of the catheter adapter 58 and the proximal end 62 of the catheter adapter 58);
a fluid collection device (Blood collection device 20; paragraph 0033); and
a flow restriction device (Abstract-- A blood collection device to reduce hemolysis; extension 50), comprising:
a male luer connector portion defining a first lumen (Male connector 26; paragraph 0030-0031);
a female luer connector portion defining a second lumen (Female connector 46; paragraph 0035); and
a tube defining a third lumen (Elongated neck 35 having fluid pathway 36 therethrough; paragraph 0032-0035), wherein the third lumen is in fluid communication with the first lumen and the second lumen (Elongated neck 35 connects the blood collection device 20 and the catheter 54 as shown in Fig. 3A-3B; paragraph 0010, 0035-0036), and
the third lumen having a diameter about 0.02 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 0.017in D show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art).
However, Ma fails to explicitly disclose wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion.
Piferi, in the same field of endeavor of a device for transferring fluid including an extension tube, teaches a device including a male luer connector portion defining a first lumen (Connector 502), a female luer connector portion defining a second lumen (Connector 505), and an extension tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Tube 510; paragraphs 0038, 0081-0085, 0091-- an extension tube assembly 500 comprising an external support tube 510 and a longitudinally extending inner tube 530 [where the inner tube serves as the third lumen]… The inner tube 230 can be aligned with and couple to the inner tube 30 in the tubular cannula 20 and to the inner tube 530 in the extension tube assembly 500), wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion (Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the tube of Ma to be more flexible than the luer connectors as described by Piferi, in order to allow the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 13, the combination of Ma and Piferi discloses the peripheral intravenous catheter assembly of claim 12. Ma additionally discloses wherein the third lumen has a length of about 1.3 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 1.6 or 1.44in L show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art Figs. 2A-2D, the fluid pathway length is shown by 38, which encompasses the third lumen 35 having the fluid pathway 36 therethrough but additionally includes the lengths of the male luer connector portion and female luer connector portion such that the length of the third lumen must be less than length 38). It is additionally noted that the claimed dimensions of a diameter of about 0.02 inches and a length of about 1.3 inches satisfy the disclosed preferred parameters of Ma of a device of diameter 20 G and D.sup.4/L is equal to or less than 3.1E-07 cubic inches and a device of diameter 22 G having D.sup.4/L is equal to or less than 1.6E-07 cubic inches, where this is determined to be an optimized ratio corresponding to a low risk of hemolysis (Paragraph 0042-- the predetermined value may correspond to a value at which the risk of hemolysis is determined to be low).
Regarding claim 14, the combination of Ma and Piferi discloses the peripheral intravenous catheter assembly of claim 12. Ma additionally discloses wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow (Paragraph 0035-- the blood collection device 20 may include an extension 50, which a user may couple to the holder 41 to provide the elongated neck 35 and an increased L, which may decrease the risk of hemolysis; Paragraph 0044-0045; Fig. 4B).
Regarding claim 16, the combination of Ma and Piferi discloses the peripheral intravenous catheter assembly of claim 12. Ma additionally discloses wherein the female luer defines an extension portion (See Fig. 2D).
Regarding claim 20, the combination of Ma and Piferi teaches the flow restriction device of claim 7. Piferi additionally teaches wherein the male luer connector portion is movable relative to the female luer connector portion (Connector 505 is connected to connector 502 via the tube 510; Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting; paragraph 0076).
It would have been obvious to one having ordinary skill in the art at the time of filing that the modification of Ma to utilize a tube more flexible than the luer connectors as described by Piferi would additionally enable the male luer connector portion to be movable relative to the female luer connector portion, thus allowing the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 21, the combination of Ma and Piferi teaches the flow restriction device of claim 12. Burkholz additionally teaches the catheter hub and fluid collection device are positioned at opposite ends of the tube (see distal end 12 and proximal end 16 of the adapter 10).
Piferi additionally teaches wherein an end of the tube is movable relative to the opposite end of the tube (Connector 505 is connected to connector 502 via the tube 510; Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting; paragraph 0076).
It would have been obvious to one having ordinary skill in the art at the time of filing that the modification of Ma to utilize a tube more flexible than the luer connectors as described by Piferi would additionally enable the device connected to male luer connector portion to be movable relative to the device connected to the female luer connector portion, thus allowing the assembly to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14, 16-18, 20-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8, 12, and 18 of copending Application No. 18315155 in view of Ma (US 20220047195 A1), further in view of Piferi.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, the reference application discloses the following limitations in each of claims 1, 8, and 18: a flow restriction device (Claim 1, line 1; claim 8, line 1; Claim 18, line 5), comprising: a male luer connector portion defining a first lumen (Claim 1, line 2; claim 8, line 2; Claim 18, line 6); a female luer connector portion defining a second lumen (Claim 1, line 3; claim 8, line 3; claim 18, line 7); and a flexible tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Claim 1, lines 4-6; claim 8, lines 4-6; claim 18, lines 8-10).
However, the reference application is silent as to the third lumen having a diameter of about 0.02 inches. Ma, in the same field of endeavor of a flow restriction device (Abstract), teaches a device having a male luer connector portion defining a first lumen (Male connector 26; paragraph 0030-0031); a female luer connector portion defining a second lumen (Female connector 46; paragraph 0035); and a tube defining a third lumen (Elongated neck 35 having fluid pathway 36 therethrough; paragraph 0032-0035), wherein the third lumen is in fluid communication with the first lumen and the second lumen (Elongated neck 35 connects the blood collection device 20 and the catheter 54 as shown in Fig. 3A-3B; paragraph 0010, 0035-0036), and the third lumen having a diameter about 0.02 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 0.017in D show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art).
It would have been obvious to one having ordinary skill in the art to modify the device of the reference application to have the fluid path dimensions disclosed by Ma in order to predictably improve the ability of the device to maintain blood flow for collection while reducing hemolysis by reducing shear stress which may be done by providing the given dimensions in a fluid pathway (see Ma, paragraph 0042).
However, the combination fails to explicitly disclose wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion.
Piferi, in the same field of endeavor of a device for transferring fluid including an extension tube, teaches a device including a male luer connector portion defining a first lumen (Connector 502), a female luer connector portion defining a second lumen (Connector 505), and an extension tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Tube 510; paragraphs 0038, 0081-0085, 0091-- an extension tube assembly 500 comprising an external support tube 510 and a longitudinally extending inner tube 530 [where the inner tube serves as the third lumen]… The inner tube 230 can be aligned with and couple to the inner tube 30 in the tubular cannula 20 and to the inner tube 530 in the extension tube assembly 500), wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion (Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the tube of the combination to be more flexible than the luer connectors as described by Piferi, in order to allow the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 2, the reference application in view of Ma and Piferi discloses the flow restriction device of claim 1 (see above). However, the reference application fails to disclose the third lumen has a length of about 1.3 inches. Ma additionally discloses wherein the third lumen has a length of about 1.3 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 1.6 or 1.44in L show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art Figs. 2A-2D, the fluid pathway length is shown by 38, which encompasses the third lumen 35 having the fluid pathway 36 therethrough but additionally includes the lengths of the male luer connector portion and female luer connector portion such that the length of the third lumen must be less than length 38). It is additionally noted that the claimed dimensions of a diameter of about 0.02 inches and a length of about 1.3 inches satisfy the disclosed preferred parameters of Ma of a device of diameter 20 G and D.sup.4/L is equal to or less than 3.1E-07 cubic inches and a device of diameter 22 G having D.sup.4/L is equal to or less than 1.6E-07 cubic inches, where this is determined to be an optimized ratio corresponding to a low risk of hemolysis (Paragraph 0042-- the predetermined value may correspond to a value at which the risk of hemolysis is determined to be low).
It would have been obvious to one having ordinary skill in the art to modify the device of the reference application to have the fluid path dimensions suggested by Ma in order to predictably improve the ability of the device to maintain blood flow for collection while reducing hemolysis by reducing shear stress which may be done by providing the given dimensions in a fluid pathway (see Ma, paragraph 0042), wherein the use of a third lumen length of about 1.3 inches may be selected through routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" and Ma has disclosed that the fluid pathway length may be selected through this process to ensure a low risk of hemolysis. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 3, the reference application further discloses: wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow (Claim 4, lines 1-3; claim 12, lines 1-3; claim 18, lines 13-15).
Regarding claim 4, the reference application further discloses wherein the male luer is configured to be coupled to a catheter hub (Claim 18, line 3). While the reference application does not explicitly disclose that the male luer is configured to be coupled to the catheter hub rather than the female luer, Ma demonstrates that it would have been obvious to one having ordinary skill in the art at the time of filing to utilize a male luer adapter to connect a flow restriction device to a catheter hub (see paragraph 0030-0032) as a matter of simple substitution of parts known in the art, where the substitution would replace an alternative means of connecting the catheter hub to the flow restriction device, such as by using the female luer.
Regarding claim 5, the reference application further discloses wherein the female luer is configured to be coupled to a fluid collection device (Claim 18, line 4). While the reference application does not explicitly disclose that the female luer is configured to be coupled to the fluid collection device rather than the male luer, Ma demonstrates that it would have been obvious to one having ordinary skill in the art at the time of filing to utilize a female luer adapter to connect a flow restriction device to a fluid collection device (see paragraph 0035) as a matter of simple substitution of parts known in the art, where the substitution would replace an alternative means of connecting the fluid collection device to the flow restriction device, such as by using the male luer.
Regarding claim 6, the reference application further discloses wherein the female luer defines an extension portion (Claim 1, line 3; claim 8, line 3; claim 18, line 7). While the reference application does not explicitly claim that the female luer defines an extension portion, by claiming that the female luer connector portion defines a second lumen, this second lumen may be seen as an extension off of the third lumen and thus the female luer itself may define an extension portion.
Regarding claim 7, the reference application discloses: a flow restriction device (Claim 1, line 1; claim 8, line 1; Claim 18, line 5), comprising: a male luer connector portion defining a first lumen (Claim 1, line 2; claim 8, line 2; Claim 18, line 6); a female luer connector portion defining a second lumen (Claim 1, line 3; claim 8, line 3; claim 18, line 7); and a flexible tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Claim 1, lines 4-6; claim 8, lines 4-6; claim 18, lines 8-10).
However, the reference does not disclose the third lumen having a diameter about 0.02 inches and a length of about 1.3 inches. Ma, in the same field of endeavor of a flow restriction device (Abstract), teaches a device having a male luer connector portion defining a first lumen (Male connector 26; paragraph 0030-0031); a female luer connector portion defining a second lumen (Female connector 46; paragraph 0035); and a tube defining a third lumen (Elongated neck 35 having fluid pathway 36 therethrough; paragraph 0032-0035), wherein the third lumen is in fluid communication with the first lumen and the second lumen (Elongated neck 35 connects the blood collection device 20 and the catheter 54 as shown in Fig. 3A-3B; paragraph 0010, 0035-0036), and the third lumen having a diameter about 0.02 inches and a length of about 1.3 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 0.017in D with 1.6 or 1.44in L show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art Figs. 2A-2D, the fluid pathway length is shown by 38, which encompasses the third lumen 35 having the fluid pathway 36 therethrough but additionally includes the lengths of the male luer connector portion and female luer connector portion such that the length of the third lumen must be less than length 38). It is additionally noted that the claimed dimensions of a diameter of about 0.02 inches and a length of about 1.3 inches satisfy the disclosed preferred parameters of Ma of a device of diameter 20 G and D.sup.4/L is equal to or less than 3.1E-07 cubic inches and a device of diameter 22 G having D.sup.4/L is equal to or less than 1.6E-07 cubic inches, where this is determined to be an optimized ratio corresponding to a low risk of hemolysis (Paragraph 0042-- the predetermined value may correspond to a value at which the risk of hemolysis is determined to be low).
It would have been obvious to one having ordinary skill in the art to modify the device of the reference application to have the fluid path dimensions suggested by Ma in order to predictably improve the ability of the device to maintain blood flow for collection while reducing hemolysis by reducing shear stress which may be done by providing the given dimensions in a fluid pathway (see Burkholz, paragraph 0035), wherein the use of a third lumen length of about 1.3 inches may be selected through routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" and Ma has disclosed that the fluid pathway length may be selected through this process to ensure a low risk of hemolysis. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
However, the combination fails to explicitly disclose wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion.
Piferi, in the same field of endeavor of a device for transferring fluid including an extension tube, teaches a device including a male luer connector portion defining a first lumen (Connector 502), a female luer connector portion defining a second lumen (Connector 505), and an extension tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Tube 510; paragraphs 0038, 0081-0085, 0091-- an extension tube assembly 500 comprising an external support tube 510 and a longitudinally extending inner tube 530 [where the inner tube serves as the third lumen]… The inner tube 230 can be aligned with and couple to the inner tube 30 in the tubular cannula 20 and to the inner tube 530 in the extension tube assembly 500), wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion (Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the tube of the combination to be more flexible than the luer connectors as described by Piferi, in order to allow the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 8, the reference application further discloses: wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow (Claim 4, lines 1-3; claim 12, lines 1-3; claim 18, lines 13-15).
Regarding claim 9, the reference application further discloses wherein the male luer is configured to be coupled to a catheter hub (Claim 18, line 3). While the reference application does not explicitly disclose that the male luer is configured to be coupled to the catheter hub rather than the female luer, Ma demonstrates that it would have been obvious to one having ordinary skill in the art at the time of filing to utilize a male luer adapter to connect a flow restriction device to a catheter hub (see paragraph 0030-0032) as a matter of simple substitution of parts known in the art, where the substitution would replace an alternative means of connecting the catheter hub to the flow restriction device, such as by using the female luer.
Regarding claim 10, the reference application further discloses wherein the female luer is configured to be coupled to a fluid collection device (Claim 18, line 4). While the reference application does not explicitly disclose that the female luer is configured to be coupled to the fluid collection device rather than the male luer, Ma demonstrates that it would have been obvious to one having ordinary skill in the art at the time of filing to utilize a female luer adapter to connect a flow restriction device to a fluid collection device (see paragraph 0035) as a matter of simple substitution of parts known in the art, where the substitution would replace an alternative means of connecting the fluid collection device to the flow restriction device, such as by using the male luer.
Regarding claim 11, the reference application further discloses wherein the female luer defines an extension portion (Claim 1, line 3; claim 8, line 3; claim 18, line 7). While the reference application does not explicitly claim that the female luer defines an extension portion, by claiming that the female luer connector portion defines a second lumen, this second lumen may be seen as an extension off of the third lumen and thus the female luer itself may define an extension portion.
Regarding claim 12, the reference application discloses a peripheral intravenous catheter assembly configured to limit hemolysis during drawing of blood from a patient (Claim 18, line 1-2), comprising: a catheter hub having a proximal end and a distal end (Claim 18, line 3); a fluid collection device (Claim 18, line 4); and a flow restriction device (Claim 18, line 5), comprising: a male luer connector portion defining a first lumen (Claim 18, line 6) wherein the male luer connector portion is coupled to the catheter hub (Claim 18, line 3); a female luer connector portion defining a second lumen (claim 18, line 7) in fluid communication with the fluid collection device (Claim 18, line 4); and a tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (claim 18, lines 8-10).
While the reference application does not explicitly disclose that the male luer is configured to be coupled to the catheter hub rather than the female luer, Ma demonstrates that it would have been obvious to one having ordinary skill in the art at the time of filing to utilize a male luer adapter to connect a flow restriction device to a catheter hub (see paragraph 0030-0032) as a matter of simple substitution of parts known in the art, where the substitution would replace an alternative means of connecting the catheter hub to the flow restriction device, such as by using the female luer. Similarly, While the reference application does not explicitly disclose that the female luer is configured to be coupled to the fluid collection device rather than the male luer, Ma demonstrates that it would have been obvious to one having ordinary skill in the art at the time of filing to utilize a female luer adapter to connect a flow restriction device to a fluid collection device (see paragraph 0035) as a matter of simple substitution of parts known in the art, where the substitution would replace an alternative means of connecting the fluid collection device to the flow restriction device, such as by using the male luer.
However, the reference application is silent as to the third lumen having a diameter of about 0.02 inches. Ma, in the same field of endeavor of a flow restriction device (Abstract), teaches a device having a male luer connector portion defining a first lumen (Male connector 26; paragraph 0030-0031); a female luer connector portion defining a second lumen (Female connector 46; paragraph 0035); and a tube defining a third lumen (Elongated neck 35 having fluid pathway 36 therethrough; paragraph 0032-0035), wherein the third lumen is in fluid communication with the first lumen and the second lumen (Elongated neck 35 connects the blood collection device 20 and the catheter 54 as shown in Fig. 3A-3B; paragraph 0010, 0035-0036), and the third lumen having a diameter about 0.02 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 0.017in D show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art).
It would have been obvious to one having ordinary skill in the art to modify the device of the reference application to have the fluid path dimensions disclosed by Ma in order to predictably improve the ability of the device to maintain blood flow for collection while reducing hemolysis by reducing shear stress which may be done by providing the given dimensions in a fluid pathway (see Ma, paragraph 0042).
However, the combination fails to explicitly disclose wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion.
Piferi, in the same field of endeavor of a device for transferring fluid including an extension tube, teaches a device including a male luer connector portion defining a first lumen (Connector 502), a female luer connector portion defining a second lumen (Connector 505), and an extension tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Tube 510; paragraphs 0038, 0081-0085, 0091-- an extension tube assembly 500 comprising an external support tube 510 and a longitudinally extending inner tube 530 [where the inner tube serves as the third lumen]… The inner tube 230 can be aligned with and couple to the inner tube 30 in the tubular cannula 20 and to the inner tube 530 in the extension tube assembly 500), wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion (Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the tube of the combination to be more flexible than the luer connectors as described by Piferi, in order to allow the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 13, the reference application fails to explicitly disclose wherein the third lumen has a length of about 1.3 inches. Ma additionally discloses wherein the third lumen has a length of about 1.3 inches (Paragraph 0013, 0042-- In some embodiments, the gauge of the peripheral intravenous catheter is 22 G, and D.sup.4/L is equal to or less than 1.6E-07 cubic inches. In some embodiments, the gauge of the peripheral intravenous catheter is 20 G, and D.sup.4/L is equal to or less than 3.1E-07 cubic inches; Paragraph 0044-0045-- Results for the blood collection device 20 having D equal to 0.024 inches and 0.017 inches are illustrated. Results for the blood collection device 20 having L equal to 1 inch, 1.6 inches, and 1.44 inches are illustrated… In some embodiments, with the peripheral intravenous catheter 54 that is 24 G, L of the fluid pathway 36 can be reduced significantly to 1.44 inches if D of the fluid pathway 36 is reduced to 0.017 inches; Fig. 4B, all of the devices with 1.6 or 1.44in L show shear stress improvements over the 25G UT prior art and several of these devices also show stress improvements over the 21G UT prior art Figs. 2A-2D, the fluid pathway length is shown by 38, which encompasses the third lumen 35 having the fluid pathway 36 therethrough but additionally includes the lengths of the male luer connector portion and female luer connector portion such that the length of the third lumen must be less than length 38). It is additionally noted that the claimed dimensions of a diameter of about 0.02 inches and a length of about 1.3 inches satisfy the disclosed preferred parameters of Ma of a device of diameter 20 G and D.sup.4/L is equal to or less than 3.1E-07 cubic inches and a device of diameter 22 G having D.sup.4/L is equal to or less than 1.6E-07 cubic inches, where this is determined to be an optimized ratio corresponding to a low risk of hemolysis (Paragraph 0042-- the predetermined value may correspond to a value at which the risk of hemolysis is determined to be low).
It would have been obvious to one having ordinary skill in the art to modify the device of the reference application to have the fluid path dimensions suggested by Ma in order to predictably improve the ability of the device to maintain blood flow for collection while reducing hemolysis by reducing shear stress which may be done by providing the given dimensions in a fluid pathway (see Ma, paragraph 0042), wherein the use of a third lumen length of about 1.3 inches may be selected through routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" and Ma has disclosed that the fluid pathway length may be selected through this process to ensure a low risk of hemolysis. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, the reference application further discloses wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow (Claim 18, lines 13-15).
Regarding claim 16, the reference application further discloses wherein the female luer defines an extension portion (claim 18, line 7). While the reference application does not explicitly claim that the female luer defines an extension portion, by claiming that the female luer connector portion defines a second lumen, this second lumen may be seen as an extension off of the third lumen and thus the female luer itself may define an extension portion.
Regarding claim 17, the combination teaches the flow restriction device of claim 1. Piferi additionally teaches wherein the male luer connector portion is movable relative to the female luer connector portion (Connector 505 is connected to connector 502 via the tube 510; Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting; paragraph 0076).
It would have been obvious to one having ordinary skill in the art at the time of filing that the modification of the reference to utilize a tube more flexible than the luer connectors as described by Piferi would additionally enable the male luer connector portion to be movable relative to the female luer connector portion, thus allowing the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 18, the combination teaches the flow restriction device of claim 1. The reference additionally teaches wherein the male luer connector portion is coupled to a first end of the tube and the female luer connector portion is coupled to a second end of the tube (Claim 1, lines 4-6; claim 8, lines 4-6; claim 18, lines 8-10).
Regarding claim 20, the combination teaches the flow restriction device of claim 7. Piferi additionally teaches wherein the male luer connector portion is movable relative to the female luer connector portion (Connector 505 is connected to connector 502 via the tube 510; Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting; paragraph 0076).
It would have been obvious to one having ordinary skill in the art at the time of filing that the modification of the reference to utilize a tube more flexible than the luer connectors as described by Piferi would additionally enable the male luer connector portion to be movable relative to the female luer connector portion, thus allowing the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 21, the combination teaches the flow restriction device of claim 12. The reference additionally teaches the catheter hub and fluid collection device are positioned at opposite ends of the tube (claim 18, lines 3-10).
Piferi additionally teaches wherein an end of the tube is movable relative to the opposite end of the tube (Connector 505 is connected to connector 502 via the tube 510; Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting; paragraph 0076).
It would have been obvious to one having ordinary skill in the art at the time of filing that the modification of Burkholz to utilize a tube more flexible than the luer connectors as described by Piferi would additionally enable the device connected to male luer connector portion to be movable relative to the device connected to the female luer connector portion, thus allowing the assembly to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
This is a provisional nonstatutory double patenting rejection.
Claims 7, 9-13, 16, and 20-21 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 and 14 of copending Application No. 18187215 in view of Piferi.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 7, each of claims 2 and 14 of the reference application discloses: a flow restriction device (Claim 1, line 1; claim 13, line 5), comprising: a male luer connector portion defining a first lumen (claim 1, line 2; claim 13, line 6); a female luer connector portion defining a second lumen (claim 1, line 3; claim 13, line 8); and a tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (claim 1, line 4-5; claim 13, line 10-11) and the third lumen having a diameter about 0.02 inches (claim 1, line 5; claim 13, line 12) and a length of about 1.3 inches (claim 2, line 1-2; claim 14, line 1-2).
However, the reference fails to explicitly disclose wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion.
Piferi, in the same field of endeavor of a device for transferring fluid including an extension tube, teaches a device including a male luer connector portion defining a first lumen (Connector 502), a female luer connector portion defining a second lumen (Connector 505), and an extension tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Tube 510; paragraphs 0038, 0081-0085, 0091-- an extension tube assembly 500 comprising an external support tube 510 and a longitudinally extending inner tube 530 [where the inner tube serves as the third lumen]… The inner tube 230 can be aligned with and couple to the inner tube 30 in the tubular cannula 20 and to the inner tube 530 in the extension tube assembly 500), wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion (Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the tube of the combination to be more flexible than the luer connectors as described by Piferi, in order to allow the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 9, the reference application further discloses wherein the male luer is configured to be coupled to a catheter hub (Claim 13, line 6-7).
Regarding claim 10, the reference application further discloses wherein the female luer is configured to be coupled to a fluid collection device (Claim 13, line 8-9).
Regarding claim 11, the reference application further discloses wherein the female luer defines an extension portion (claim 13, lines 8-9). While the reference application does not explicitly claim that the female luer defines an extension portion, by claiming that the female luer connector portion defines a second lumen, this second lumen may be seen as an extension off of the third lumen and thus the female luer itself may define an extension portion.
Regarding claim 12, the reference application discloses a peripheral intravenous catheter assembly configured to limit hemolysis during drawing of blood from a patient (Claim 13, line 1-2), comprising: a catheter hub having a proximal end and a distal end (Claim 13, line 3); a fluid collection device (Claim 13, line 4); and a flow restriction device (Claim 13, line 5), comprising: a male luer connector portion defining a first lumen (Claim 13, line 6) wherein the male luer connector portion is coupled to the catheter hub (Claim 13, line 6-7); a female luer connector portion defining a second lumen (claim 13, line 8) in fluid communication with the fluid collection device (Claim 13, line 8-9); and a tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (claim 13, lines 10-11) and the third lumen having a diameter of about 0.02 inches (Claim 13, line 11).
However, the reference fails to explicitly disclose wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion.
Piferi, in the same field of endeavor of a device for transferring fluid including an extension tube, teaches a device including a male luer connector portion defining a first lumen (Connector 502), a female luer connector portion defining a second lumen (Connector 505), and an extension tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Tube 510; paragraphs 0038, 0081-0085, 0091-- an extension tube assembly 500 comprising an external support tube 510 and a longitudinally extending inner tube 530 [where the inner tube serves as the third lumen]… The inner tube 230 can be aligned with and couple to the inner tube 30 in the tubular cannula 20 and to the inner tube 530 in the extension tube assembly 500), wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion (Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the tube of the combination to be more flexible than the luer connectors as described by Piferi, in order to allow the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 13, the reference application further discloses wherein the third lumen has a length of about 1.3 inches (Claim 14, line 1-2).
Regarding claim 16, the reference application further discloses wherein the female luer defines an extension portion (claim 13, line 8-9). While the reference application does not explicitly claim that the female luer defines an extension portion, by claiming that the female luer connector portion defines a second lumen, this second lumen may be seen as an extension off of the third lumen and thus the female luer itself may define an extension portion.
Regarding claim 20, the combination teaches the flow restriction device of claim 7. Piferi additionally teaches wherein the male luer connector portion is movable relative to the female luer connector portion (Connector 505 is connected to connector 502 via the tube 510; Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting; paragraph 0076).
It would have been obvious to one having ordinary skill in the art at the time of filing that the modification of the reference to utilize a tube more flexible than the luer connectors as described by Piferi would additionally enable the male luer connector portion to be movable relative to the female luer connector portion, thus allowing the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 21, the combination teaches the flow restriction device of claim 12. The reference additionally teaches the catheter hub and fluid collection device are positioned at opposite ends of the tube (Claim 13, line 3-10).
Piferi additionally teaches wherein an end of the tube is movable relative to the opposite end of the tube (Connector 505 is connected to connector 502 via the tube 510; Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting; paragraph 0076).
It would have been obvious to one having ordinary skill in the art at the time of filing that the modification of Burkholz to utilize a tube more flexible than the luer connectors as described by Piferi would additionally enable the device connected to male luer connector portion to be movable relative to the device connected to the female luer connector portion, thus allowing the assembly to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Claims 1-6, 8, 14, and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 and 14 of copending Application No. 18187215 in view of Burkholz, further in view of Piferi.
Regarding claim 1, each of claims 2 and 14 of the reference application discloses: a male luer connector portion defining a first lumen (claim 1, line 2; claim 13, line 6); a female luer connector portion defining a second lumen (claim 1, line 3; claim 13, line 8); and a tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (claim 1, line 4-5; claim 13, line 10-11) and the third lumen having a diameter about 0.02 inches (claim 1, line 5; claim 13, line 12).
However, the reference fails to disclose the tube is flexible.
Burkholz, in the same field of endeavor of a flow restriction device for reducing hemolysis, discloses an extension is a flexible tube (Figs. 1A-4B, nonlinear portion 22/tube 28 is a helical tube arranged between the male luer portion 14 and the female luer portion 18; paragraph 0035-- the non-linear portion 22 may form a coil shape, an S-shape, or another suitable shape. As illustrated in FIGS. 1A-1B, in some embodiments, the non-linear portion 22 may include the coil shape, which may include a spiral).
It would have been obvious to one having ordinary skill in the art to modify the device of the reference application to have a flexible tube in order to predictably improve the ability of the device to further reduce hemolysis which may be done by providing a nonlinear shape to the tube (see Burkholz, paragraph 0035).
However, the combination fails to explicitly disclose wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion.
Piferi, in the same field of endeavor of a device for transferring fluid including an extension tube, teaches a device including a male luer connector portion defining a first lumen (Connector 502), a female luer connector portion defining a second lumen (Connector 505), and an extension tube defining a third lumen, wherein the third lumen is in fluid communication with the first lumen and the second lumen (Tube 510; paragraphs 0038, 0081-0085, 0091-- an extension tube assembly 500 comprising an external support tube 510 and a longitudinally extending inner tube 530 [where the inner tube serves as the third lumen]… The inner tube 230 can be aligned with and couple to the inner tube 30 in the tubular cannula 20 and to the inner tube 530 in the extension tube assembly 500), wherein the tube is flexible compared to the male luer connector portion and the female luer connector portion (Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the tube of the combination to be more flexible than the luer connectors as described by Piferi, in order to allow the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 2, the reference application further discloses a length of about 1.3 inches (claim 2, line 1-2; claim 14, line 1-2).
Regarding claim 3, the reference application in view of Burkholz discloses a flow restriction device as discussed above. However, claims 2 and 14 of the reference fail to disclose wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow.
Burkholz additionally teaches wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow (Paragraph 0034-0041-- the non-linear portion may facilitate increased flow resistance within the vascular access system to distribute the pressure differential and reduce shear stress experienced by red blood cells… the fluid pathway 20 may include a length L… the fluid pathway 20 may include an inner diameter D…). It would have been obvious to one having ordinary skill in the art to utilize the device of the reference application to increase the flow resistance through the lumen to predictably improve the usability of a blood sample collected using the device by reducing the effects of shear stress on red blood cells in the fluid collected (see Burkholz, paragraph 0035).
Regarding claim 4, the reference further discloses the male luer is configured to be coupled to a catheter hub (Claim 13, line 6-7).
Regarding claim 5, the reference further discloses wherein the female luer is configured to couple to a fluid collection device (Claim 13, line 8-9).
Regarding claim 6, the reference application further discloses wherein the female luer defines an extension portion (claim 13, line 8-9). While the reference application does not explicitly claim that the female luer defines an extension portion, by claiming that the female luer connector portion defines a second lumen, this second lumen may be seen as an extension off of the third lumen and thus the female luer itself may define an extension portion.
Regarding claim 8, the reference application discloses a flow restriction device as discussed above. However, claims 2 and 14 of the reference fail to disclose wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow.
Burkholz additionally teaches wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow (Paragraph 0034-0041-- the non-linear portion may facilitate increased flow resistance within the vascular access system to distribute the pressure differential and reduce shear stress experienced by red blood cells… the fluid pathway 20 may include a length L… the fluid pathway 20 may include an inner diameter D…). It would have been obvious to one having ordinary skill in the art to utilize the device of the reference application to increase the flow resistance through the lumen to predictably improve the usability of a blood sample collected using the device by reducing the effects of shear stress on red blood cells in the fluid collected (see Burkholz, paragraph 0035).
Regarding claim 14, the reference application discloses a peripheral intravenous catheter assembly as discussed above. However, claims 2 and 14 of the reference fail to disclose wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow.
Burkholz additionally teaches wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow (Paragraph 0034-0041-- the non-linear portion may facilitate increased flow resistance within the vascular access system to distribute the pressure differential and reduce shear stress experienced by red blood cells… the fluid pathway 20 may include a length L… the fluid pathway 20 may include an inner diameter D…). It would have been obvious to one having ordinary skill in the art to utilize the device of the reference application to increase the flow resistance through the lumen to predictably improve the usability of a blood sample collected using the device by reducing the effects of shear stress on red blood cells in the fluid collected (see Burkholz, paragraph 0035).
Regarding claim 17, the combination teaches the flow restriction device of claim 1. Piferi additionally teaches wherein the male luer connector portion is movable relative to the female luer connector portion (Connector 505 is connected to connector 502 via the tube 510; Paragraph 0038, 0081, 0100-- external support tube 510 can be polymeric flexible tubing…; Paragraph 0115, 0120—stiff connection of respective luer fitting; paragraph 0076).
It would have been obvious to one having ordinary skill in the art at the time of filing that the modification of the reference to utilize a tube more flexible than the luer connectors as described by Piferi would additionally enable the male luer connector portion to be movable relative to the female luer connector portion, thus allowing the device to be rolled, coiled, or folded for predictably improved ease of storage and tubing management (see Piferi, paragraph 0076).
Regarding claim 18, the combination teaches the flow restriction device of claim 1. The reference additionally teaches wherein the male luer connector portion is coupled to a first end of the tube and the female luer connector portion is coupled to a second end of the tube (claim 1, line 4-5; claim 13, line 10-11).
Regarding claim 19, the combination teaches the flow restriction device of claim 1. Burkholz additionally teaches that an inner diameter may vary over the length of the fluid pathway such that the diameter of the third lumen may be smaller than a first diameter of the first lumen and a second diameter of the second lumen (Paragraph 0038-0039; Fig. 3B, 4B, 5). It would have been obvious to one having ordinary skill in the art at the time of filing to further modify the device of the reference to include a change in diameter of the flow path according to Burkholz in order to further modify the fluid resistance of the fluid pathway to predictably improve the hemolysis reduction of the system.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-21 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. In particular, new reference Piferi has been used to update the rejections of the claims under 35 U.S.C. 103 and double patenting.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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/ANNA ROBERTS/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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