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 Amendments filed 04/01/2026 have been entered.
Claims 1, 7, 8 and 20 have thereby been amended.
Claims 21-27 have been added.
Claims 10-19 have been cancelled.
Claims 1-9 and 20-27 are being examined in this office action.
Claim Interpretation
The phrases “a male luer connector portion configured to couple to a catheter assembly” and “a female luer connector portion…configured to couple to a fluid collection device” recited in claim 1 are interpreted as functional limitations. As such, claim 1 is interpreted such that the claim requires a male luer connector and a female luer connector, but does not require a catheter assembly or a fluid collection device. Dependent claims 7 and 8 which recite the fluid collection device from claim 1 are also interpreted as functional limitations in the same manner as claim 1 from which they depend upon.
The phrase “configured to limit hemolysis” recited in claims 9 and 20 are also interpreted as functional limitations. As such, claims 9 and 20 are interpreted as only requiring the structures of the device and assembly, including the micro-channel, as they are claimed, in order to be capable of performing the same limitation of hemolysis as the claimed device/assembly does.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Caron (US 5409477) in view of Kim (US 20210379298).
Regarding claim 1,Caron discloses a flow restriction device (Fig. 2: 12), comprising: a male luer connector portion (Fig. 2: end 56; col. 3, lines 50-54) configured to couple to a catheter assembly, the male luer connector portion comprising an internal surface defining a lumen thereof (Fig. 2: internal lumen at 28); a female luer connector portion disposed proximally to the male luer connector portion (Fig. 2: end 32; col. 4, lines 25-27) and configured to couple to a fluid collection device, the female luer connector portion comprising an internal surface defining a lumen (Fig. 2: internal lumen at 26) fluidly connected to the lumen of the male luer connector portion (Figs. 2 and 3: lumen connecting 26 to 28 via channel 48); and a body portion extending between the male luer portion and the female luer portion (Fig. 2: body 24), and integrally formed with the male luer portion and the female luer portion to form a single monolithic piece (Fig. 2: a singular, integrated, monolithic body extending from 26 to 28), the body portion comprising a recess extending longitudinally therethrough (Fig. 2: 42) and fluidly communicated with the lumens of the male luer portion and the female luer portion (Fig. 2: 26 fluidly connected to 28 via recess 42 and channel 48), wherein the recess defines a micro-channel (Fig. 3: 48) from the male luer connector portion to the female luer connector portion such that a fluid can flow into the fluid collection device via the female luer connector portion (col. 3, lines 19-24). Although Caron does not explicitly disclose the male luer configured to couple to a catheter assembly, or the female luer being configured to couple to a fluid collection device, this functional language has been carefully considered but deemed not to impose any structural limitation on the claim distinguishable over the structure of the male and female luer connector portions disclosed by Caron, since the language does not require a catheter assembly or fluid collection device, but rather merely the ability for the flow restriction device to be coupled to them. Luer connectors are known in the art to be regularly connected to catheter assemblies and to fluid collection devices. Since the male and female luer connector portions of Caron have the same structures as claimed, a person of ordinary skill in the art would be able to couple the Caron male luer to a catheter assembly to be able to access the vasculature of a patient for use with the flow restrictor device, and would be able to couple the Caron female luer to a fluid collection device in order to collect blood from the vasculature of the patient. However, although the microchannel of Caron is disclosed as connecting the flow from the female luer end to the male luer end, Caron fails to disclose that the micro-channel extends fully between the connector ends.
Kim teaches an analogous flow restriction device (Fig. 5: 800) wherein the recess defines a micro-channel (Fig. 5: 820p) from the male luer connector portion (Fig. 5: O2) to the female luer connector portion (Fig. 5: O1; 820p extends fully from the end of the O1 luer to the end of the O2 luer). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the micro-channel of the Caron device by making it extend all the way from the male luer connector portion to the female luer connector portion, as taught by Kim, in order to create more flow restriction and further reduce the flow rate, and to reduce additional turbulence caused by a shorter microchannel with less flow restriction. Furthermore, as the length of the micro-channel is a result-effective variable that affects the fluid flow through the device, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Caron device by increasing the length of the micro-channel as taught by Kim as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (See MPEP 2144.05(II)).
Regarding claim 2, Caron in view of Kim teaches the flow restriction device of claim 1, as described above, wherein an outer surface of the body portion comprises a plurality of laterally extending ribs disposed about and surrounding a longitudinal axis of the body portion, the plurality of ribs being spaced apart from each other along the longitudinal axis between the female luer connector portion and the male luer connector portion (Caron: Fig. 2: ribs 58, 60, 62).
Regarding claim 7, Caron in view of Kim teaches the flow restriction device of claim 1, as described above, wherein the flow restriction device is configured to transport blood from the male luer connector portion into the fluid collection device via the female luer connector portion (Caron: col. 29, lines 49-51). The limitations of the fluid comprising blood and the fluid collection device comprising a blood collection device are functional limitations (see Claim Interpretation above), and therefore would occur if the flow restriction device were to be used with a vascular catheter assembly and a fluid collection device which would thereby collect blood, which the Caron device has the capability of being coupled to via the luer connectors, as described above in the rejection of claim 1.
Regarding claim 8, Caron in view of Kim teaches the flow restriction device of claim 7, as described above, wherein the female luer connector portion is configured to couple to a blood collection device. Although Caron in view of Kim does not explicitly disclose a blood collection device, since the male and female luer connector portions of Caron have the same structures as claimed, they would be able to be used in the same manner set forth in the claim, being that a blood collection device would be capable to be coupled to the female luer connector.
Regarding claim 21, Caron in view of Kim teaches the flow restriction device of claim 7, as described above, wherein the female luer connector portion is configured to couple to a luer lock access device. Although Caron in view of Kim does not explicitly disclose a luer lock access device, since the male and female luer connector portions of Caron have the same structures as claimed, they would be able to be used in the same manner set forth in the claim, being that a luer lock access device would be capable to be coupled to the female luer connector.
Regarding claim 22, Caron in view of Kim teaches the flow restriction device of claim 1, as described above, but fails to explicitly teach the micro channel having a diameter of 0.02-0.025 inches. However, this parameter of the diameter of the micro-channel is a result effective variable. Kim teaches the micro-channel having a diameter of 0.04-0.008 mm, smaller than the claimed 0.02-0.025 inches, to create increased fluid restriction and reduced fluid flow. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter of the Caron-Kim micro-channel to be 0.02-0.025 inches to create the target range for fluid velocity and fluid pressure flowing through. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameter of the Caron-Kim micro-channel to be 0.02-0.025 inches as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (See MPEP 2144.05(II)).
Regarding claim 23, Caron in view of Kim teaches the flow restriction device of claim 1, as described above, but fails to explicitly disclose the length of the micro-channel as being between 1 inch and 1.3 inches. However, as the length of the micro-channel is a result-effective variable that affects the fluid flow through the device, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the Caron-Kim micro-channel to be 1-1.3 inches as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (See MPEP 2144.05(II)).
Regarding claim 24, Caron in view of Kim teaches the flow restriction device of claim 1, as described above, but fails to explicitly disclose the length to diameter ratio of the micro-channel as being between 65 and 40. However, as the length-diameter ratio of the micro-channel is a result-effective variable that affects the fluid flow through the device, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the Caron-Kim micro-channel to have a length-diameter ratio of 40-65 as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (See MPEP 2144.05(II)).
Claims 3-6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Caron (US 5409477) in view of Kim (US 20210379298) in further view of Fangrow (US 20060161115), herein referred to as Fangrow’115
Regarding claim 3, Caron in view of Kim teaches the flow restriction device of claim 2, as described above, but fails to disclose a longitudinal rib disposed across the lateral ribs.
Fangrow’115 teaches an analogous medical connector body (Fig. 2: 12) wherein the outer surface of the body portion further comprises at least one longitudinally extending rib disposed along the longitudinal axis and extending from the male luer connector portion to the female luer connector portion (Fig. 2: longitudinal ribs 62). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Caron- device to include the longitudinal rib(s) taught by Fangrow’115 in order to provide more structural stability to the lateral ribs and create spaces for other devices to securely connect to the device.
Regarding claim 4, Caron in view of Kim in further view of Fangrow’115 teaches the flow restriction device of claim 3, as described above, wherein the longitudinally extending rib is disposed transverse to and interconnects each of the laterally extending ribs (Fangrow’115: Fig. 2: 62 transverse to lateral ribs 60a-c). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the Caron-Fangrow’115 device to include the interconnecting longitudinal and lateral ribs taught by Fangrow’115 in order to provide more structural stability to the lateral ribs and create spaces for other devices to securely connect to the device.
Regarding claim 5, Caron in view of Kim in further view of Fangrow’115 teaches the flow restriction device of claim 3, as described above, wherein the least one longitudinally extending rib comprises a pair of longitudinally extending ribs disposed on opposing sides of the outer surface of the body portion (Fangrow’115: Fig. 5: longitudinal ribs 62 disposed on opposite sides of the body). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the Caron-Fangrow’115 device to include the pair of opposing longitudinal ribs taught by Fangrow’115 in order to provide more structural stability to the lateral ribs and create spaces for other devices to securely connect to the device.
Regarding claim 6, Caron in view of Kim in further view of Fangrow’115 teaches the flow restriction device of claim 5, as described above, wherein the pair of longitudinally extending ribs are disposed transverse to and interconnect each of the laterally extending ribs on opposing sides of the outer surface of the body portion (Fangrow’115: Fig. 2: 62 transverse to and interconnected with lateral ribs 60a-c). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the Caron-Fangrow’115 device to include the interconnecting longitudinal and lateral ribs on opposing sides of the body, taught by Fangrow’115, in order to provide more structural stability to the lateral ribs and create spaces for other devices to securely connect to the device.
Regarding claim 20, Caron discloses a peripheral intravenous catheter assembly configured to limit hemolysis during the drawing of blood from a patient, comprising: a flow restriction device (Fig. 2: 12), comprising: a male luer connector portion (Fig. 2: end 56; col. 3, lines 50-54) configured to couple to a catheter assembly, the male luer connector portion comprising an internal surface defining a lumen thereof (Fig. 2: internal lumen at 28); a female luer connector portion disposed proximally to the male luer connector portion (Fig. 2: end 32; col. 4, lines 25-27) and configured to couple to a fluid collection device, the female luer connector portion comprising an internal surface defining a lumen (Fig. 2: internal lumen at 26) fluidly connected to the lumen of the male luer connector portion (Figs. 2 and 3: lumen connecting 26 to 28 via channel 48); and a body portion extending between the male luer portion and the female luer portion (Fig. 2: body 24), and integrally formed with the male luer portion and the female luer portion to form a single monolithic piece (Fig. 2: a singular, integrated, monolithic body extending from 26 to 28), the body portion comprising a recess extending longitudinally therethrough (Fig. 2: 42) and fluidly communicated with the lumens of the male luer portion and the female luer portion (Fig. 2: 26 fluidly connected to 28 via recess 42 and channel 48), wherein the recess defines a micro-channel (Fig. 3: 48), the micro-channel configured to limit hemolysis of blood as the blood is drawn from a patient from the male luer connector portion into the fluid collection device via the female luer connector portion (col. 3, lines 19-24). Although Caron does not explicitly disclose the male luer configured to couple to a catheter assembly, or the female luer being configured to couple to a fluid collection device, this functional language has been carefully considered but deemed not to impose any structural limitation on the claim distinguishable over the structure of the male and female luer connector portions disclosed by Caron. Since the male and female luer connector portions of Caron have the same structures as claimed, they would be able to be used in the same manner set forth in the claim, being that a catheter assembly be coupled to the male luer connector and a fluid collection device be coupled to the female luer connector. Additionally, although Caron does not explicitly disclose the micro-channel configured to limit hemolysis of blood as the blood is drawn from a patient, the recitations of this limitation is merely functional language (see Claim Interpretation above). As such, because the micro-channel of Caron reads on all the claimed structural limitations of the micro-channel of the claimed invention, one of ordinary skill would conclude that the Caron micro-channel would be capable of performing the limitation of hemolysis in the same manner as the claimed micro-channel. However, although the microchannel of Caron is disclosed as connecting the flow from the female luer end to the male luer end, Caron fails to disclose that the micro-channel extends fully between the connector ends.
Kim teaches an analogous flow restriction device (Fig. 5: 800) with a micro-channel (Fig. 5: 820p) extending from the male luer connector portion (Fig. 5: O2) to the female luer connector portion (Fig. 5: O1; 820p extends fully from the end of the O1 luer to the end of the O2 luer). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the micro-channel of the Caron device by making it extend all the way from the male luer connector portion to the female luer connector portion, as taught by Kim, in order to create more flow restriction and further reduce the flow rate, and to reduce additional turbulence caused by a shorter microchannel with less flow restriction. Furthermore, as the length of the micro-channel is a result-effective variable that affects the fluid flow through the device, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Caron device by increasing the length of the micro-channel as taught by Kim as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (See MPEP 2144.05(II)). However, Caron in view of Kim also fails to explicitly disclose a catheter hub being coupled to the flow restriction device.
Fangrow’115 teaches an analogous flow restrictor connector with a catheter hub having a proximal end and a distal end and a fluid connector that fluidly couples the catheter hub with the flow restriction device (para. [0060], sentence 2). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the connection of the restriction device to a catheter hub, taught by Fangrow’115, into the Caron-Kim device/assembly in order to use the restrictor device with an already placed veinous catheter for blood draw applications.
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Fangrow (US 20060161115), herein referred to Fangrow’115 in view of Olson (US 20050234499).
Regarding claim 9, Fangrow’115 discloses a method for manufacturing (para. [0015]) a flow restriction device (para. [0071], sentence 2) with a female luer connector on the opposite end of the male luer connector (Fig. 2: 16 opposite of and fluidly coupled to 32) and ribs surrounding the micro-channel (Fig. 2: ribs 60a-c). However, Fangrow’115 discloses the device being molded in multiple pieces that are later assembled (para. [0066], last sentence), and fails to disclose a method for manufacturing a single monolithic piece device.
Olson teaches an analogous general method of manufacturing a single monolithic piece device, the method comprising: providing first and second mold parts (Fig. 4A: 69 and 71; para. [0044], sentence 2), each of the first and second mold parts comprising an imprint recessed therein (Fig. 4B: imprint 70; para. [0044], sentence 2), the imprint comprising a male luer connector imprint portion at a distal end portion of the first mold part (Figs. 3 and 4B: male luer connectors 41 and 43 with their imprints shown in Fig. 4B; para. [0039], sentence 1), a micro-channel imprint portion extending longitudinally between the male luer connector imprint portion and the other end (Figs. 3 and 4B: channels 46 and 47 extending longitudinal between); inserting a male luer connector mold part into the male luer connector imprint portion (Fig. 4B: 75 and 78 inserted); inserting a female luer connector mold part into the female luer connector imprint portion (Fig. 4B: tube 32 inserted), the female luer connector mold part comprising a micro-channel mold part extending from a distal end of the female luer connector mold part (Fig. 4B: 74 and 76; para. [0045], sentences 1-3), wherein the micro-channel mold part (74 and 76; para. [0045], sentences 1-3) is inserted into the micro-channel imprint portion (Fig. 4B: 74 and 76 inserted into 70; para. [0045], sentences 1-3); coupling the first and second mold parts to form a mold assembly (para. [0043], sentences 5-7); injecting a molten mold material into the mold assembly (para. [0043], sentence 6); and cooling the mold assembly (para. [0050], sentences 1-2). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Fangrow’115 method of manufacturing with steps of the molding method taught by Olson, in order to manufacture the flow restriction device in a single monolithic piece, rather than in separate pieces that must be assembled, so that the final device can be a strong monolithic piece less likely to break apart while in use.
Additionally, although Fangrow’115 does not explicitly disclose that the micro-channel configured to limit hemolysis of blood as the blood is drawn from a patient, the recitations of this limitation is merely functional language (see Claim Interpretation above). As such, because the micro-channel of Fangrow’115 reads on all the claimed structural limitations of the micro-channel of the claimed invention, one of ordinary skill would conclude that the Fangrow’115 micro-channel would be capable of performing the limitation of hemolysis in the same manner as the claimed micro-channel.
Regarding claim 25, Fangrow’115 in view of Olson teaches the method of claim 9, as described above, but fails to explicitly teach the micro channel having a diameter of 0.02-0.025 inches. However, this parameter of the diameter of the micro-channel is a result effective variable. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter of the Fangrow’115-Olson micro-channel to be 0.02-0.025 inches to create the target range for fluid velocity and fluid pressure flowing through. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameter of the Fangrow’115-Olson micro-channel to be 0.02-0.025 inches as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (See MPEP 2144.05(II)).
Regarding claim 26, Fangrow’115 in view of Olson teaches the method of claim 9, as described above, but fails to explicitly disclose the length of the micro-channel as being between 1 inch and 1.3 inches. However, as the length of the micro-channel is a result-effective variable that affects the fluid flow through the device, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the Fangrow’115-Olson micro-channel to be 1-1.3 inches as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (See MPEP 2144.05(II)).
Regarding claim 27, Fangrow’115 in view of Olson teaches the method of claim 9, as described above, wherein inserting the female luer connector mold part into the female luer connector imprint portion comprises inserting the micro-channel mold part into the micro-channel imprint portion such that the micro-channel mold part extends longitudinally between the male luer connector mold part and the female luer connector mold part (Olson: Fig. 4B: the channel mold being inserted into and extending all the way through both the luer connector ends; para. [0043]).
Response to Arguments
Applicant’s arguments with respect to the prior art rejections, filed 04/01/2026, have been considered but are moot because of the new ground of rejections in light of the amendments. Independent claims 1 and 20 no longer solely rely on Caron to teach the micro-channel, and now rely on Kim to teach the length of the micro-channel extending between the male and female luer connector portions.
For these reasons, claims 1-9 and 20-27 stand rejected as recited above.
Conclusion
THIS ACTION IS MADE FINAL. 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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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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