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 27 March 2026 has been entered. Claim(s) 1 and 4-22 are pending in the application; claims 2-3 are canceled.
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 and 4-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20210228127 A1).
Regarding claim 1, a first embodiment of 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 middle connector portion (Middle portion 32) comprising a helically wound flexible tubing comprising a first end and a second end (Nonlinear portion 22 which extends through tube 28; see helical shape of tube 28 extending between a first end and a second end between the male luer portion 14 and the female luer portion 18 in Figs. 1A-4B; paragraph 0035—non-linear portion 22 may form a coil shape…which may include a spiral…), the first end fluidically coupled to the first lumen and the second end fluidically coupled to 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);
such that a fluid passage through the tubing is configured to provide fluid communication between 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).
Burkholz separately teaches a second embodiment where the middle connector portion comprises a solid core extending between the male and female luer connector portions about which a non-linear portion extends helically (See Fig. 6A-6C, nonlinear portion 22 formed through grooves 56 in the solid core inner component 58; paragraph 0055-0060-- the non-linear portion 22 of the fluid pathway 20 may include a channel or a groove 56. In some embodiments, the groove 56 may be disposed in an outer surface of an inner component 58, which may be coupled to an outer component 60. In some embodiments, the groove 56 may include a coil or spiral shape.), wherein this solid core includes a helical path about the core which comprises a first end fluidically coupled to the first lumen and a second end fluidically coupled to the second lumen such that a fluid passage through this non-linear portion is configured to provide fluid communication between the first lumen and the second lumen (Paragraphs 0055-0060-- seal element 61 may prevent fluid from escaping the groove 56 except at a distal end and a proximal end of the groove 56… a proximal end of the groove 56 may include a hole 62 that may fluidically connect the groove 56 to an opening 63 of the proximal end 16. Similarly, in some embodiments, a distal end of the groove 56 may include a hole that may fluidically connect the groove 56 to an opening 64 of the distal end 12; see Figs. 6A-6C demonstrating the arrangement of the grooved core relative to the first and second lumens).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the first embodiment of Burkholz, which utilizes helically coiled tubing for reducing hemolysis, with the second embodiment of Burkholz which includes a solid core having helical grooves for reducing hemolysis, to utilize a solid core having grooves and helically coiled tubing, where the tubes would extend through the grooves in order to predictably improve the stability of the tubing structure by providing a support structure that prevents the tubing from collapsing or unwinding out of its helical arrangement to maintain the hemolysis-reducing spiral structure in a compact adapter (see paragraph 0043-- the non-linear portion 22 may reduce the risk of hemolysis, while at the same time facilitating a compact adapter 10), where the combination of the tube and solid core would secure the ends of the tube (see paragraph 0043) and would permit a fluid pathway to flow through the grooved structure between the first and second lumens without any fluid escaping (see paragraph 0056-0057).
Regarding claim 4, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 1. The first embodiment of Burkholz additionally teaches wherein the fluid passage comprises a length and a diameter that is configured to increase flow resistance through the tubing to reduce shear stress on the fluid (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 5, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 1. The first embodiment of Burkholz additionally teaches wherein the middle connector portion comprises a hollow chamber within which the tubing extends between the male and female luer connector portions (lumen 30; paragraph 0044—the tube 28 may be disposed within the lumen 30).
Regarding claim 6, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 1. The first embodiment of Burkholz additionally teaches wherein the tubing is helically wound within the hollow chamber (See Figs. 1A-4B, paragraph 0035).
Regarding claim 7, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 1. The first embodiment of Burkholz additionally teaches wherein the first end of the tubing is coupled to the first lumen through a first port formed in the male luer connector portion, and the second end of the tubing is coupled to the second lumen through a second port formed in the female luer connector portion (See Figs. 1A-4B, non-linear portion 22/tube 28 is coupled via the open ends/port of the tube 28 to the lumens of each of the male connector 14 and female connector 18 to form the fluid pathway 20; paragraphs 0033-0036—fluid pathway).
Regarding claim 8, a first embodiment of Burkholz teaches a flow restriction device (10), comprising:
a first connector portion defining a first lumen (Distal connector 14; paragraph 0029-- the distal connector 14 may include a male luer threaded connector);
a second 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 third connector portion (Middle portion 32) comprising a tubing with a first end and a second end (Nonlinear portion 22 which extends through tube 28), the first end configured to fluidly couple with the first lumen and the second end configured to fluidly couple with 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);
wherein the tubing is helically wound (Nonlinear portion 22 which extends through tube 28; see helical shape of tube 28 extending between a first end and a second end between the male luer portion 14 and the female luer portion 18 in Figs. 1A-4B; paragraph 0035—non-linear portion 22 may form a coil shape…which may include a spiral…) and comprises a fluid passage that is configured to provide fluid communication between 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).
A second embodiment of Burkholz separately teaches an embodiment where the third connector portion comprises a core extending between the first and second connector portions about which a non-linear portion extends helically (See Fig. 6A-6C, nonlinear portion 22 formed through grooves 56 in the solid core inner component 58; paragraph 0055-0060-- the non-linear portion 22 of the fluid pathway 20 may include a channel or a groove 56. In some embodiments, the groove 56 may be disposed in an outer surface of an inner component 58, which may be coupled to an outer component 60. In some embodiments, the groove 56 may include a coil or spiral shape.), wherein this core includes a helical path about the core comprising a first end fluidically coupled to the first lumen and a second end fluidically coupled to the second lumen such that a fluid passage through this non-linear portion is configured to provide fluid communication between the first lumen and the second lumen (Paragraphs 0055-0060-- seal element 61 may prevent fluid from escaping the groove 56 except at a distal end and a proximal end of the groove 56… a proximal end of the groove 56 may include a hole 62 that may fluidically connect the groove 56 to an opening 63 of the proximal end 16. Similarly, in some embodiments, a distal end of the groove 56 may include a hole that may fluidically connect the groove 56 to an opening 64 of the distal end 12; see Figs. 6A-6C demonstrating the arrangement of the grooved core relative to the first and second lumens).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the first embodiment of Burkholz, which utilizes helically coiled tubing for reducing hemolysis, with the second embodiment of Burkholz which includes a core having helical grooves for reducing hemolysis, to utilize a solid core having grooves and helically coiled tubing, where the tubes would extend through the grooves in order to predictably improve the stability of the tubing structure by providing a support structure that prevents the tubing from collapsing or unwinding out of its helical arrangement to maintain the hemolysis-reducing spiral structure in a compact adapter (see paragraph 0043-- the non-linear portion 22 may reduce the risk of hemolysis, while at the same time facilitating a compact adapter 10), where the combination of the tube and core would secure the ends of the tube (see paragraph 0043) and would permit a fluid pathway to flow through the grooved structure between the first and second lumens without any fluid escaping (see paragraph 0056-0057).
Regarding claim 9, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 8. The first embodiment of Burkholz discloses a tubing (tube 28), while the second embodiment of Burkholz teaches a core extending between the first and second connector portions about which a non-linear portion extends helically (See Fig. 6A-6C, nonlinear portion 22 formed through grooves 56 in the solid core inner component 58; paragraph 0055-0060).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the first embodiment of Burkholz, which utilizes helically coiled tubing, with the second embodiment of Burkholz which includes a core having grooves for reducing hemolysis, to utilize a core having grooves which support the tubing in order to predictably improve the stability of the tubing structure by providing a support structure that prevents the tubing from collapsing or unwinding out of its helical arrangement to maintain the hemolysis-reducing spiral structure in a compact adapter (see paragraph 0043-- the non-linear portion 22 may reduce the risk of hemolysis, while at the same time facilitating a compact adapter 10), where the combination of the tube and solid core would secure the ends of the tube (see paragraph 0043) and would permit a fluid pathway to flow through the grooved structure between the first and second lumens without any fluid escaping (see paragraph 0056-0057).
Regarding claim 10, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 9. The first embodiment of Burkholz additionally teaches wherein the tubing is flexible and is helically wound in the middle connector portion (Figs. 1A-4B, paragraph 0035).
Regarding claim 11, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 9. The first embodiment of Burkholz additionally teaches wherein fluid is conducted through tubing which is helically wound in the middle connector portion (Figs. 1A-4B, paragraph 0035) and in a second embodiment, wherein the core is a solid core that does not conduct fluid and comprises a helically wound groove that forms a trough and ridges to secure placement of a non-linear portion therethrough (Fig. 6A-6C nonlinear portion 22 formed through grooves 56 in the solid core inner component 58, paragraph 0055-0060).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the first embodiment of Burkholz, which utilizes helically coiled tubing, with the embodiment of Burkholz which includes a solid core having grooves for reducing hemolysis, to utilize a solid core having grooves which support the tubing in order to predictably improve the stability of the tubing structure by providing a support structure that prevents the tubing from collapsing or unwinding out of its helical arrangement to maintain the hemolysis-reducing spiral structure in a compact adapter (see paragraph 0043-- the non-linear portion 22 may reduce the risk of hemolysis, while at the same time facilitating a compact adapter 10), where the combination of the tube and solid core would secure the ends of the tube (see paragraph 0043) and would permit a fluid pathway to flow through the grooved structure between the first and second lumens without any fluid escaping (see paragraph 0056-0057).
Regarding claim 12, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 8. The first embodiment of Burkholz additionally teaches wherein the fluid passage comprises a length and a diameter that is configured to increase flow resistance through the tubing to reduce shear stress on the fluid (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 13, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 8. The first embodiment of Burkholz additionally teaches wherein the third connector portion comprises a hollow chamber within which the tubing extends between the first and second connector portions (lumen 30; paragraph 0044—the tube 28 may be disposed within the lumen 30).
Regarding claim 14, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 8. The first embodiment of Burkholz additionally teaches wherein the tubing is helically wound within the hollow chamber (See Figs. 1A-4B; paragraph 0035, 0044).
Regarding claim 15, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 8. The first embodiment of Burkholz additionally teaches wherein the first end of the tubing is coupled to the first lumen through a first port formed in the male luer connector portion, and the second end of the tubing is coupled to the second lumen through a second port formed in the female luer connector portion (See Figs. 1A-4B, non-linear portion 22/tube 28 is coupled via the open ends/port of the tube 28 to the lumens of each of the male connector 14 and female connector 18 to form the fluid pathway 20; paragraphs 0033-0036—fluid pathway).
Regarding claim 16, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 8. The first embodiment of Burkholz additionally teaches wherein at least one of the first connector portion and second connector portion comprises a luer connector (Paragraph 0029, 0033-- the proximal connector 18 may include a female luer connector or another suitable connector… the proximal connector 18 may include a female luer connector or another suitable connector).
Regarding claim 17, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 8. The first embodiment of Burkholz additionally teaches wherein the third connector portion extends between the first and second connector portions (See Figs. 1A-4B).
Regarding claim 18, a first embodiment of 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 middle connector portion (Middle portion 32) comprising a flexible tubing which is helically wound and comprises a first end and a second end (Nonlinear portion 22 which extends through tube 28; see helical shape of tube 28 extending between a first end and a second end between the male luer portion 14 and the female luer portion 18 in Figs. 1A-4B; paragraph 0035—non-linear portion 22 may form a coil shape…which may include a spiral…), the first end fluidically coupled to the first lumen and the second end fluidically coupled to 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);
wherein the tubing comprises a fluid passage that
(i) is configured to provide fluid communication between 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) and
(ii) comprises a length and a diameter that is configured to increase flow resistance through the tubing to reduce shear stress on the fluid (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…).
A second embodiment of Burkholz separately teaches an embodiment where the third connector portion comprises a core extending between the first and second connector portions about which a non-linear portion extends helically (See Fig. 6A-6C, nonlinear portion 22 formed through grooves 56 in the solid core inner component 58; paragraph 0055-0060-- the non-linear portion 22 of the fluid pathway 20 may include a channel or a groove 56. In some embodiments, the groove 56 may be disposed in an outer surface of an inner component 58, which may be coupled to an outer component 60. In some embodiments, the groove 56 may include a coil or spiral shape.), wherein this core includes a helical path about the core comprising a first end fluidically coupled to the first lumen and a second end fluidically coupled to the second lumen such that a fluid passage through this non-linear portion is configured to provide fluid communication between the first lumen and the second lumen (Paragraphs 0055-0060-- seal element 61 may prevent fluid from escaping the groove 56 except at a distal end and a proximal end of the groove 56… a proximal end of the groove 56 may include a hole 62 that may fluidically connect the groove 56 to an opening 63 of the proximal end 16. Similarly, in some embodiments, a distal end of the groove 56 may include a hole that may fluidically connect the groove 56 to an opening 64 of the distal end 12; see Figs. 6A-6C demonstrating the arrangement of the grooved core relative to the first and second lumens).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the first embodiment of Burkholz, which utilizes helically coiled tubing for reducing hemolysis, with the second embodiment of Burkholz which includes a core having helical grooves for reducing hemolysis, to utilize a solid core having grooves and helically coiled tubing, where the tubes would extend through the grooves in order to predictably improve the stability of the tubing structure by providing a support structure that prevents the tubing from collapsing or unwinding out of its helical arrangement to maintain the hemolysis-reducing spiral structure in a compact adapter (see paragraph 0043-- the non-linear portion 22 may reduce the risk of hemolysis, while at the same time facilitating a compact adapter 10), where the combination of the tube and core would secure the ends of the tube (see paragraph 0043) and would permit a fluid pathway to flow through the grooved structure between the first and second lumens without any fluid escaping (see paragraph 0056-0057).
Regarding claim 19, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 1. The second embodiment of Burkholz teaches an embodiment where the middle connector portion comprises a solid core about which a non-linear portion extends helically (See Fig. 6A-6C, nonlinear portion 22 formed through grooves 56 in the solid core inner component 58; paragraph 0055-0060).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the first embodiment of Burkholz, which utilizes helically coiled tubing, with the embodiment of Burkholz which includes a solid core having grooves for reducing hemolysis, to utilize a solid core having grooves which support the tubing in order to predictably improve the stability of the tubing structure by providing a support structure that prevents the tubing from collapsing or unwinding out of its helical arrangement to maintain the hemolysis-reducing spiral structure in a compact adapter (see paragraph 0043-- the non-linear portion 22 may reduce the risk of hemolysis, while at the same time facilitating a compact adapter 10), where the combination of the tube and solid core would secure the ends of the tube (see paragraph 0043) and would permit a fluid pathway to flow through the grooved structure between the first and second lumens without any fluid escaping (see paragraph 0056-0057).
Regarding claim 20, the combination of the first and second embodiments of Burkholz teaches the peripheral intravenous catheter assembly of claim 18. The first embodiment of Burkholz additionally teaches wherein the middle connector portion comprises a hollow chamber within which the tubing is helically wound between the male and female luer connector portions (lumen 30; paragraph 0035, 0044—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…the tube 28 may be disposed within the lumen 30; Figs. 1A-4B).
Regarding claim 21, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 1. The first embodiment of Burkholz additionally teaches wherein fluid is conducted through tubing which is helically wound in the middle connector portion (Figs. 1A-4B, paragraph 0035).
The second embodiment of Burkholz additionally teaches wherein the core is a solid core that does not conduct fluid (Inner component 58 including groove 56 does not conduct fluid through the inner component but about the inner component in the groove; paragraph 0055-0060-- fluid flowing through the groove 56 may not escape the groove 56 except at a distal end and a proximal end of the groove 56) and comprises a helically wound groove that provides a trough and ridges (Groove 56; paragraphs 0055-0060).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the first embodiment of Burkholz, which utilizes helically coiled tubing, with the second embodiment of Burkholz which includes a solid core having grooves for reducing hemolysis, to utilize a solid core having grooves about which the tubing is supported in order to predictably improve the stability of the tubing structure by providing a support structure that prevents the tubing from collapsing or unwinding out of its helical arrangement to maintain the hemolysis-reducing spiral structure in a compact adapter (see paragraph 0043-- the non-linear portion 22 may reduce the risk of hemolysis, while at the same time facilitating a compact adapter 10), where the combination of the tube and solid core would secure the ends of the tube (see paragraph 0043) and would permit a fluid pathway to flow through the grooved structure between the first and second lumens without any fluid escaping (see paragraph 0056-0057).
Regarding claim 22, the combination of the first and second embodiments of Burkholz teaches the flow restriction device of claim 21. The second embodiment of Burkholz additionally teaches wherein the ridges extend between or along adjacent coils of the tubing (See Figs. 6A and 6C, wherein ridges extend between adjacent “coils” of the groove 56, where the tubing would be placed in the described combination of the first and second embodiment of Burkholz).
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, 4, 8, 12, 16, 18, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 13, and 15 of copending Application No. 18/187,215 in view of Burkholz (US 20210228127 A1).
While the reference application discloses a flow restriction device comprising a male luer connector portion defining a first lumen, a female luer connector portion defining a second lumen, and a tubing defining a third lumen which is in fluid communication with the first lumen and the second lumen, wherein the fluid passage comprises a length and a diameter that is configured to increase flow resistance through the tubing to reduce shear stress on the fluid and a peripheral intravenous catheter assembly configured to limit hemolysis during drawing of blood from a patient, comprising: a catheter hub having a proximal end and a distal end; and a fluid collection device, it fails to specifically disclose a core extending between the male and female luer connector portions and a flexible tubing helically wound around the core.
Burkholz, in the same field of endeavor of a flow restriction device for reducing hemolysis, discloses tubing is helically arranged between the male luer connector portion and the female luer connector portion (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 at the time of filing to modify the device of the reference application to have a helical tubing arrangement as disclosed by Burkholz in order to predictably improve the flow resistance of the tubing by modifying the direction of fluid flow (see Burkholz, paragraph 0034-0035).
A second embodiment of Burkholz separately teaches an embodiment where the third connector portion comprises a core extending between the first and second connector portions about which a non-linear portion extends helically (See Fig. 6A-6C, nonlinear portion 22 formed through grooves 56 in the solid core inner component 58; paragraph 0055-0060-- the non-linear portion 22 of the fluid pathway 20 may include a channel or a groove 56. In some embodiments, the groove 56 may be disposed in an outer surface of an inner component 58, which may be coupled to an outer component 60. In some embodiments, the groove 56 may include a coil or spiral shape.), wherein this core includes a helical path about the core comprising a first end fluidically coupled to the first lumen and a second end fluidically coupled to the second lumen such that a fluid passage through this non-linear portion is configured to provide fluid communication between the first lumen and the second lumen (Paragraphs 0055-0060-- seal element 61 may prevent fluid from escaping the groove 56 except at a distal end and a proximal end of the groove 56… a proximal end of the groove 56 may include a hole 62 that may fluidically connect the groove 56 to an opening 63 of the proximal end 16. Similarly, in some embodiments, a distal end of the groove 56 may include a hole that may fluidically connect the groove 56 to an opening 64 of the distal end 12; see Figs. 6A-6C demonstrating the arrangement of the grooved core relative to the first and second lumens). The second embodiment of Burkholz additionally teaches wherein the core is a solid core that does not conduct fluid (Inner component 58 including groove 56 does not conduct fluid through the inner component but about the inner component in the groove; paragraph 0055-0060-- fluid flowing through the groove 56 may not escape the groove 56 except at a distal end and a proximal end of the groove 56) and comprises a helically wound groove that provides a trough and ridges (Groove 56; paragraphs 0055-0060) wherein the ridges extend between or along adjacent coils of the tubing (See Figs. 6A and 6C, wherein ridges extend between adjacent “coils” of the groove 56, where the tubing would be placed in the described combination of the first and second embodiment of Burkholz).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the combined reference application and first embodiment of Burkholz, which utilizes helically coiled tubing for reducing hemolysis, with the second embodiment of Burkholz which includes a core having helical grooves for reducing hemolysis, to utilize a solid core having grooves and helically coiled tubing, where the tubes would extend through the grooves in order to predictably improve the stability of the tubing structure by providing a support structure that prevents the tubing from collapsing or unwinding out of its helical arrangement to maintain the hemolysis-reducing spiral structure in a compact adapter (see paragraph 0043-- the non-linear portion 22 may reduce the risk of hemolysis, while at the same time facilitating a compact adapter 10), where the combination of the tube and core would secure the ends of the tube (see paragraph 0043) and would permit a fluid pathway to flow through the grooved structure between the first and second lumens without any fluid escaping (see paragraph 0056-0057).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4, 8, 12, 16, 18, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3-5, 7-10, 12, and 14-15 of copending Application No. 18/356,651 in view of Burkholz (US 20210228127 A1).
While the reference application discloses a flow restriction device comprising a male luer connector portion defining a first lumen, a female luer connector portion defining a second lumen, and a tubing defining a third lumen which is in fluid communication with the first lumen and the second lumen, wherein the fluid passage comprises a length and a diameter that is configured to increase flow resistance through the tubing to reduce shear stress on the fluid and a peripheral intravenous catheter assembly configured to limit hemolysis during drawing of blood from a patient, comprising: a catheter hub having a proximal end and a distal end; and a fluid collection device, it fails to specifically disclose wherein the tubing is helically arranged between the male luer connector portion and the female luer connector portion.
Burkholz, in the same field of endeavor of a flow restriction device for reducing hemolysis, discloses tubing is helically arranged between the male luer connector portion and the female luer connector portion (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 at the time of filing to modify the device of the reference application to have a helical tubing arrangement as disclosed by Burkholz in order to predictably improve the flow resistance of the tubing by modifying the direction of fluid flow (see Burkholz, paragraph 0034-0035).
A second embodiment of Burkholz separately teaches an embodiment where the third connector portion comprises a core extending between the first and second connector portions about which a non-linear portion extends helically (See Fig. 6A-6C, nonlinear portion 22 formed through grooves 56 in the solid core inner component 58; paragraph 0055-0060-- the non-linear portion 22 of the fluid pathway 20 may include a channel or a groove 56. In some embodiments, the groove 56 may be disposed in an outer surface of an inner component 58, which may be coupled to an outer component 60. In some embodiments, the groove 56 may include a coil or spiral shape.), wherein this core includes a helical path about the core comprising a first end fluidically coupled to the first lumen and a second end fluidically coupled to the second lumen such that a fluid passage through this non-linear portion is configured to provide fluid communication between the first lumen and the second lumen (Paragraphs 0055-0060-- seal element 61 may prevent fluid from escaping the groove 56 except at a distal end and a proximal end of the groove 56… a proximal end of the groove 56 may include a hole 62 that may fluidically connect the groove 56 to an opening 63 of the proximal end 16. Similarly, in some embodiments, a distal end of the groove 56 may include a hole that may fluidically connect the groove 56 to an opening 64 of the distal end 12; see Figs. 6A-6C demonstrating the arrangement of the grooved core relative to the first and second lumens). The second embodiment of Burkholz additionally teaches wherein the core is a solid core that does not conduct fluid (Inner component 58 including groove 56 does not conduct fluid through the inner component but about the inner component in the groove; paragraph 0055-0060-- fluid flowing through the groove 56 may not escape the groove 56 except at a distal end and a proximal end of the groove 56) and comprises a helically wound groove that provides a trough and ridges (Groove 56; paragraphs 0055-0060) wherein the ridges extend between or along adjacent coils of the tubing (See Figs. 6A and 6C, wherein ridges extend between adjacent “coils” of the groove 56, where the tubing would be placed in the described combination of the first and second embodiment of Burkholz).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the combined reference application and first embodiment of Burkholz, which utilizes helically coiled tubing for reducing hemolysis, with the second embodiment of Burkholz which includes a core having helical grooves for reducing hemolysis, to utilize a solid core having grooves and helically coiled tubing, where the tubes would extend through the grooves in order to predictably improve the stability of the tubing structure by providing a support structure that prevents the tubing from collapsing or unwinding out of its helical arrangement to maintain the hemolysis-reducing spiral structure in a compact adapter (see paragraph 0043-- the non-linear portion 22 may reduce the risk of hemolysis, while at the same time facilitating a compact adapter 10), where the combination of the tube and core would secure the ends of the tube (see paragraph 0043) and would permit a fluid pathway to flow through the grooved structure between the first and second lumens without any fluid escaping (see paragraph 0056-0057).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 30 January 2026 have been fully considered but they are not persuasive.
In particular, the applicant argues the Burkholz fails to disclose or suggest the “middle connector portion comprising a core extending between the male and female luer connector portions, and a flexible tubing helically wound around the core” and the “fluid passage through the tubing is configured to provide fluid communication between the first and the second lumen”. As noted above in this action, combination of a first embodiment and a second embodiment of Burkholz appears sufficient to disclose the claimed limitations, where the first embodiment discloses a helically wound tubing which is configured to be secured at least at the ends of the tubing to promote a compact structure and the second embodiment discloses a helical groove around a core which limits a fluid pathway to pass through the groove, wherein such a modified structure would thus appear to be motivated by the stated goals of Burkholz (see paragraph 0043).
The provisional nonstatutory obviousness-type double patenting rejections have been updated to reflect the amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANNA ROBERTS/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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