DETAILED ACTION
This office action is responsive to the amendment filed 6/8/2026. Claims 1-2, 6, 34-36, and 42-43 remain pending and under prosecution.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No elements are interpreted under 112(f).
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, 6, 34-36, and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Bullington et al (US Pub No. 20140039348 – cited by applicant) in view of Percarpio (US Pat No. 4106497 – cited by applicant).
In regard to Claims 1 and 34, Bullington et al discloses a device 300 comprising:
an inlet port 322 for receiving a blood sample, best seen in Figure 13-15 – “inlet port 322 is further configured to be fluidically coupled to a medical device (not shown) defining a fluid flow pathway for withdrawing and/or conveying the bodily-fluid from a patient to the transfer device 300… the inlet port 322 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) as described above” (0068, 0073);
an outlet port 326, best seen in Figure 13-15 – “second outlet port 326 of the diverter 320 defines a second outlet lumen 327 and is configured to be coupled to an external fluid reservoir” (0085), wherein the outlet port is also defined by 324, best seen in Figure 13-15 – “ first outlet port 324 of the diverter 320 defines a first outlet lumen 325” (0069);
a chamber 338 (first lumen) connected at a proximal end with the inlet port, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330… define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
at a distal end with the outlet port portion 325 as defined above, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330, and the first outlet lumen 325 of the first outlet port 324 define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
the chamber leads to fluid reservoir 370 configured to collect a first portion of the blood sample, best seen in Figure 14 – “with the inlet port 322 coupled to the lumen-defining device, the first fluid flow path places the fluid reservoir 370 in fluid communication with the portion of the patient (e.g., the vein) and at least a portion of the suction force (e.g., applied by the negative pressure differential, as described above) is introduced to the portion of the patient. Thus, a bodily-fluid can be drawn into the fluid reservoir 370” (0076),
wherein the chamber has a fixed length during collection of the first portion of the blood sample, best seen in Figure 14; and
a sampling channel 339 (second lumen) connected with the inlet port and outlet port portion 326 as defined above, best seen in Figure 13-15, and
configured to convey a subsequent portion of the blood sample through the sampling channel to the outlet port while bypassing the chamber 338, best seen in Figure 15 – “the first lumen 338 is fluidically isolated from the inlet lumen 323 and the first outlet lumen 325, and the second lumen 339 is placed in fluid communication with the inlet lumen 323 defined by the inlet port 322 and the second outlet lumen 327 defined by the second outlet port 326” (0079),
“the second lumen 339 of the flow control mechanism 330, and the second outlet lumen 327 of the second outlet port 326 define a second fluid flow path that can place the external reservoir (not shown in FIG. 15) in fluid communication with the inlet port 322 and, therefore, the portion of the patient (e.g., the vein) … The negative pressure within the external reservoir… introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir 370” (0080); and
a housing 301 that fully encloses the inlet port, the outlet port 324, 326, the chamber 338, and the sampling channel 339, best seen in Figure 12-13 (0070),
wherein the chamber 338 and the sampling channel 339 have a fixed relationship with the housing during the collecting, as shown in Figure 14, and the bypassing, as shown in Figure 14 – “the flow control mechanism 330 moves concurrently with the actuator 340 when the actuator 340 is rotated relative to the housing 301. In this manner, the flow control mechanism 330 can be moved relative to the diverter 320 to place the first lumen 338 or the second lumen 339 in fluid communication with the inlet port 322, the first outlet port 324, and/or the second outlet port 326” (0072). In other words, after the pathway is selected, the chamber or sampling channel have a fixed relationship with the housing during the collecting and the bypassing.
However, Bullington et al do not expressly disclose the chamber including a material that is air permeable and blood impermeable/air permeable blood barrier.
Percarpio teach that it is well-known in the art to provide an analogous blood sampling device comprising a blood barrier 90 disposed in the housing 26, 40 with chamber 32 defined therein and an outlet at proximal end of valve 78, best seen in Figure 2-3, the blood barrier being gas permeable – “Three spaced channels 92 are formed in the film to provide air passageways for facilitating venting of the assembly and flow of blood into the indicator area where film 90 is located” (Col.4: 16-22) – and blood impermeable – “expansion of the film due to contact with the liquid closes channels 92 and locks the blood into the area of the location of the film and prevents leakage beyond the rear flanged end 36 of hub 26” (Col.4: 16-27) – to enable venting of the device during sampling as well as provide a visual indication of flashback of initial blood into the device that does not consequently contaminate the subsequently sampled portion of blood – “The walls of hub 26 surrounding the film 90 are transparent or translucent so that the blood captured by the film and indicating a successful veni-puncture is observable by the operator. The expansion of the film to close off the channels prevents leakage of the blood beyond the rear end of the hub and eliminates the danger of possible contamination of the surrounding area including the operator. Furthermore, by capturing the blood within the indicator area including channels 92, there is no danger of contamination of blood being collected into chamber 32 and ultimately into an evacuated container through the passageway interconnected with rear needle 50” (Col.4: 27-39).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Bullington et al such that the chamber includes a material that is air permeable and blood impermeable/air permeable blood barrier to effectively enable venting of the device during sampling as well as provide a visual indication of flashback of initial blood into the device that does not consequently contaminate the subsequently sampled portion of blood as taught by Percarpio.
2, 35. Percarpio teach the material 90 is configured to seal upon contact with the first portion of the blood sample (Col.4: 16-39).
6, 36. Bullington et al disclose the device is configured with a moving part 340, 345, 346 (actuator mechanism with engagement portion 345 and activation portion 346 to control flow mechanism 330) that is movable from a first position, best seen in Figure 14 – “a user can begin the transfer of a bodily-fluid by applying an activation force to the engagement portion 344 of the actuator 340, thereby moving the actuator 340 to a second position, as shown by the arrow II in FIG. 14… thereby placing the transfer device 300 in the second configuration” (0075),
to a second position, best seen in Figure 15, to allow blood to bypass the chamber 338
and go through the sampling channel 339 – “transfer device 300 can be moved from the second configuration to the third configuration by moving the actuator mechanism 340 in the direction of the arrow KK in FIG. 15… In this manner, the first lumen 338 is fluidically isolated from the inlet lumen 323 and the first outlet lumen 325, and the second lumen 339 is placed in fluid communication with the inlet lumen 323 defined by the inlet port 322” (0079-0080).
42, 43. Bullington et al disclose the device in accordance with claim 1, wherein the outlet port 326 is configured to deliver the subsequent portion of the blood sample from the sampling channel 339 to a blood collection device separate from the device, i.e. external reservoir not shown in Figure 15 – “the inlet lumen 323 of the inlet port 322, the second lumen 339 of the flow control mechanism 330, and the second outlet lumen 327 of the second outlet port 326 define a second fluid flow path that can place the external reservoir (not shown in FIG. 15) in fluid communication with the inlet port 322 and, therefore, the portion of the patient (e.g., the vein)” (0080).
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.
Claim 1 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12 and 18 of U.S. Patent No. 11617525 in view of Bullington et al (US Pub No. 20140039348 – cited by applicant).
The Patent discloses an inlet port for receiving a blood sample; an outlet port; a chamber connected at the inlet port and configured to collect a first portion of the blood sample, the chamber including a material that is air permeable and blood impermeable/air permeable blood barrier; a sampling channel connected with the inlet port and the outlet port and configured to convey a subsequent portion of the blood sample to the outlet port while bypassing the chamber; and a housing that fully encloses the inlet port, the outlet port, the chamber, and the sampling channel.
However, the Patent does not expressly disclose the chamber connected at a proximal end with the inlet port and at a distal end with the outlet port, and the chamber has a fixed length during collection of the first portion of the blood sample.
Bullington et al discloses an analogous device 300 comprising:
an inlet port 322 for receiving a blood sample, best seen in Figure 13-15 – “inlet port 322 is further configured to be fluidically coupled to a medical device (not shown) defining a fluid flow pathway for withdrawing and/or conveying the bodily-fluid from a patient to the transfer device 300… the inlet port 322 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) as described above” (0068, 0073);
an outlet port 326, best seen in Figure 13-15 – “second outlet port 326 of the diverter 320 defines a second outlet lumen 327 and is configured to be coupled to an external fluid reservoir” (0085), wherein the outlet port is also defined by 324, best seen in Figure 13-15 – “first outlet port 324 of the diverter 320 defines a first outlet lumen 325” (0069);
a chamber 338 (first lumen) connected at a proximal end with the inlet port, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330… define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
at a distal end with the outlet port portion 325 as defined above, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330, and the first outlet lumen 325 of the first outlet port 324 define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
the chamber leads to fluid reservoir 370 configured to collect a first portion of the blood sample, best seen in Figure 14 – “with the inlet port 322 coupled to the lumen-defining device, the first fluid flow path places the fluid reservoir 370 in fluid communication with the portion of the patient (e.g., the vein) and at least a portion of the suction force (e.g., applied by the negative pressure differential, as described above) is introduced to the portion of the patient. Thus, a bodily-fluid can be drawn into the fluid reservoir 370” (0076),
wherein the chamber has a fixed length during collection of the first portion of the blood sample, best seen in Figure 14; and
a sampling channel 339 (second lumen) connected with the inlet port and outlet port portion 326 as defined above, best seen in Figure 13-15, and
configured to convey a subsequent portion of the blood sample through the sampling channel to the outlet port while bypassing the chamber 338, best seen in Figure 15 – “the first lumen 338 is fluidically isolated from the inlet lumen 323 and the first outlet lumen 325, and the second lumen 339 is placed in fluid communication with the inlet lumen 323 defined by the inlet port 322 and the second outlet lumen 327 defined by the second outlet port 326” (0079),
“the second lumen 339 of the flow control mechanism 330, and the second outlet lumen 327 of the second outlet port 326 define a second fluid flow path that can place the external reservoir (not shown in FIG. 15) in fluid communication with the inlet port 322 and, therefore, the portion of the patient (e.g., the vein) … The negative pressure within the external reservoir… introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir 370” (0080); and
a housing 301 that fully encloses the inlet port, the outlet port 324, 326, the chamber 338, and the sampling channel 339, best seen in Figure 12-13 (0070),
wherein the chamber 338 and the sampling channel 339 have a fixed relationship with the housing during the collecting, as shown in Figure 14, and the bypassing, as shown in Figure 14 – “the flow control mechanism 330 moves concurrently with the actuator 340 when the actuator 340 is rotated relative to the housing 301. In this manner, the flow control mechanism 330 can be moved relative to the diverter 320 to place the first lumen 338 or the second lumen 339 in fluid communication with the inlet port 322, the first outlet port 324, and/or the second outlet port 326” (0072). In other words, after the pathway is selected, the chamber or sampling channel have a fixed relationship with the housing during the collecting and the bypassing.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Patent such that the chamber is connected at a proximal end with the inlet port and at a distal end with the outlet port as well as the chamber has a fixed length during collection of the first portion of the blood sample as taught by Bullington et al in the manner above as an effective configuration for the desired blood flow and subsequent collection.
Claim 1 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12257051 in view of Bullington et al (US Pub No. 20140039348 – cited by applicant).
The Patent discloses an inlet port for receiving a blood sample; an outlet port; a chamber connected at the inlet port and configured to collect a first portion of the blood sample, the chamber including a material that is air permeable and blood impermeable/air permeable blood barrier; a sampling channel connected with the inlet port and the outlet port and configured to convey a subsequent portion of the blood sample to the outlet port while bypassing the chamber; and a housing that defines the inlet port, the outlet port, the chamber, and the sampling channel.
However, the Patent does not expressly disclose the chamber connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, nor the chamber has a fixed length during collection of the first portion of the blood sample.
Bullington et al discloses an analogous device 300 comprising:
an inlet port 322 for receiving a blood sample, best seen in Figure 13-15 – “inlet port 322 is further configured to be fluidically coupled to a medical device (not shown) defining a fluid flow pathway for withdrawing and/or conveying the bodily-fluid from a patient to the transfer device 300… the inlet port 322 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) as described above” (0068, 0073);
an outlet port 326, best seen in Figure 13-15 – “second outlet port 326 of the diverter 320 defines a second outlet lumen 327 and is configured to be coupled to an external fluid reservoir” (0085), wherein the outlet port is also defined by 324, best seen in Figure 13-15 – “ first outlet port 324 of the diverter 320 defines a first outlet lumen 325” (0069);
a chamber 338 (first lumen) connected at a proximal end with the inlet port, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330… define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
at a distal end with the outlet port portion 325 as defined above, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330, and the first outlet lumen 325 of the first outlet port 324 define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
the chamber leads to fluid reservoir 370 configured to collect a first portion of the blood sample, best seen in Figure 14 – “with the inlet port 322 coupled to the lumen-defining device, the first fluid flow path places the fluid reservoir 370 in fluid communication with the portion of the patient (e.g., the vein) and at least a portion of the suction force (e.g., applied by the negative pressure differential, as described above) is introduced to the portion of the patient. Thus, a bodily-fluid can be drawn into the fluid reservoir 370” (0076),
wherein the chamber has a fixed length during collection of the first portion of the blood sample, best seen in Figure 14; and
a sampling channel 339 (second lumen) connected with the inlet port and outlet port portion 326 as defined above, best seen in Figure 13-15, and
configured to convey a subsequent portion of the blood sample through the sampling channel to the outlet port while bypassing the chamber 338, best seen in Figure 15 – “the first lumen 338 is fluidically isolated from the inlet lumen 323 and the first outlet lumen 325, and the second lumen 339 is placed in fluid communication with the inlet lumen 323 defined by the inlet port 322 and the second outlet lumen 327 defined by the second outlet port 326” (0079),
“the second lumen 339 of the flow control mechanism 330, and the second outlet lumen 327 of the second outlet port 326 define a second fluid flow path that can place the external reservoir (not shown in FIG. 15) in fluid communication with the inlet port 322 and, therefore, the portion of the patient (e.g., the vein) … The negative pressure within the external reservoir… introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir 370” (0080); and
a housing 301 that fully encloses the inlet port, the outlet port 324, 326, the chamber 338, and the sampling channel 339, best seen in Figure 12-13 (0070),
wherein the chamber 338 and the sampling channel 339 have a fixed relationship with the housing during the collecting, as shown in Figure 14, and the bypassing, as shown in Figure 14 – “the flow control mechanism 330 moves concurrently with the actuator 340 when the actuator 340 is rotated relative to the housing 301. In this manner, the flow control mechanism 330 can be moved relative to the diverter 320 to place the first lumen 338 or the second lumen 339 in fluid communication with the inlet port 322, the first outlet port 324, and/or the second outlet port 326” (0072). In other words, after the pathway is selected, the chamber or sampling channel have a fixed relationship with the housing during the collecting and the bypassing.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Patent such that the chamber is connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, and the chamber has a fixed length during collection of the first portion of the blood sample as taught by Bullington et al in the manner above as an effective configuration for the desired blood flow and subsequent collection.
Claim 1 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10827964 in view of Bullington et al (US Pub No. 20140039348 – cited by applicant).
The Patent discloses an inlet port for receiving a blood sample; an outlet port; a chamber connected at the inlet port and configured to collect a first portion of the blood sample, the chamber including a material that is air permeable and blood impermeable/air permeable blood barrier; a sampling channel connected with the inlet port and the outlet port and configured to convey a subsequent portion of the blood sample to the outlet port while bypassing the chamber; and a housing that defines the inlet port, the outlet port, the chamber, and the sampling channel.
However, the Patent does not expressly disclose the chamber connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, nor the chamber has a fixed length during collection of the first portion of the blood sample.
Bullington et al discloses an analogous device 300 comprising:
an inlet port 322 for receiving a blood sample, best seen in Figure 13-15 – “inlet port 322 is further configured to be fluidically coupled to a medical device (not shown) defining a fluid flow pathway for withdrawing and/or conveying the bodily-fluid from a patient to the transfer device 300… the inlet port 322 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) as described above” (0068, 0073);
an outlet port 326, best seen in Figure 13-15 – “second outlet port 326 of the diverter 320 defines a second outlet lumen 327 and is configured to be coupled to an external fluid reservoir” (0085), wherein the outlet port is also defined by 324, best seen in Figure 13-15 – “first outlet port 324 of the diverter 320 defines a first outlet lumen 325” (0069);
a chamber 338 (first lumen) connected at a proximal end with the inlet port, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330… define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
at a distal end with the outlet port portion 325 as defined above, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330, and the first outlet lumen 325 of the first outlet port 324 define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
the chamber leads to fluid reservoir 370 configured to collect a first portion of the blood sample, best seen in Figure 14 – “with the inlet port 322 coupled to the lumen-defining device, the first fluid flow path places the fluid reservoir 370 in fluid communication with the portion of the patient (e.g., the vein) and at least a portion of the suction force (e.g., applied by the negative pressure differential, as described above) is introduced to the portion of the patient. Thus, a bodily-fluid can be drawn into the fluid reservoir 370” (0076),
wherein the chamber has a fixed length during collection of the first portion of the blood sample, best seen in Figure 14; and
a sampling channel 339 (second lumen) connected with the inlet port and outlet port portion 326 as defined above, best seen in Figure 13-15, and
configured to convey a subsequent portion of the blood sample through the sampling channel to the outlet port while bypassing the chamber 338, best seen in Figure 15 – “the first lumen 338 is fluidically isolated from the inlet lumen 323 and the first outlet lumen 325, and the second lumen 339 is placed in fluid communication with the inlet lumen 323 defined by the inlet port 322 and the second outlet lumen 327 defined by the second outlet port 326” (0079),
“the second lumen 339 of the flow control mechanism 330, and the second outlet lumen 327 of the second outlet port 326 define a second fluid flow path that can place the external reservoir (not shown in FIG. 15) in fluid communication with the inlet port 322 and, therefore, the portion of the patient (e.g., the vein)… The negative pressure within the external reservoir… introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir 370” (0080); and
a housing 301 that fully encloses the inlet port, the outlet port 324, 326, the chamber 338, and the sampling channel 339, best seen in Figure 12-13 (0070),
wherein the chamber 338 and the sampling channel 339 have a fixed relationship with the housing during the collecting, as shown in Figure 14, and the bypassing, as shown in Figure 14 – “the flow control mechanism 330 moves concurrently with the actuator 340 when the actuator 340 is rotated relative to the housing 301. In this manner, the flow control mechanism 330 can be moved relative to the diverter 320 to place the first lumen 338 or the second lumen 339 in fluid communication with the inlet port 322, the first outlet port 324, and/or the second outlet port 326” (0072). In other words, after the pathway is selected, the chamber or sampling channel have a fixed relationship with the housing during the collecting and the bypassing.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Patent such that the chamber is connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, and the chamber has a fixed length during collection of the first portion of the blood sample as taught by Bullington et al in the manner above as an effective configuration for the desired blood flow and subsequent collection.
Claim 1 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11744494 in view of Bullington et al (US Pub No. 20140039348 – cited by applicant).
The Patent discloses an inlet port for receiving a blood sample; an outlet port; a chamber connected at the inlet port and configured to collect a first portion of the blood sample, the chamber including a material that is air permeable and blood impermeable/air permeable blood barrier; a sampling channel connected with the inlet port and the outlet port and configured to convey a subsequent portion of the blood sample to the outlet port while bypassing the chamber; and a housing that defines the inlet port, the outlet port, the chamber, and the sampling channel.
However, the Patent does not expressly disclose the chamber connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, nor the chamber has a fixed length during collection of the first portion of the blood sample.
Bullington et al discloses an analogous device 300 comprising:
an inlet port 322 for receiving a blood sample, best seen in Figure 13-15 – “inlet port 322 is further configured to be fluidically coupled to a medical device (not shown) defining a fluid flow pathway for withdrawing and/or conveying the bodily-fluid from a patient to the transfer device 300… the inlet port 322 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) as described above” (0068, 0073);
an outlet port 326, best seen in Figure 13-15 – “second outlet port 326 of the diverter 320 defines a second outlet lumen 327 and is configured to be coupled to an external fluid reservoir” (0085), wherein the outlet port is also defined by 324, best seen in Figure 13-15 – “first outlet port 324 of the diverter 320 defines a first outlet lumen 325” (0069);
a chamber 338 (first lumen) connected at a proximal end with the inlet port, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330… define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
at a distal end with the outlet port portion 325 as defined above, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330, and the first outlet lumen 325 of the first outlet port 324 define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
the chamber leads to fluid reservoir 370 configured to collect a first portion of the blood sample, best seen in Figure 14 – “with the inlet port 322 coupled to the lumen-defining device, the first fluid flow path places the fluid reservoir 370 in fluid communication with the portion of the patient (e.g., the vein) and at least a portion of the suction force (e.g., applied by the negative pressure differential, as described above) is introduced to the portion of the patient. Thus, a bodily-fluid can be drawn into the fluid reservoir 370” (0076),
wherein the chamber has a fixed length during collection of the first portion of the blood sample, best seen in Figure 14; and
a sampling channel 339 (second lumen) connected with the inlet port and outlet port portion 326 as defined above, best seen in Figure 13-15, and
configured to convey a subsequent portion of the blood sample through the sampling channel to the outlet port while bypassing the chamber 338, best seen in Figure 15 – “the first lumen 338 is fluidically isolated from the inlet lumen 323 and the first outlet lumen 325, and the second lumen 339 is placed in fluid communication with the inlet lumen 323 defined by the inlet port 322 and the second outlet lumen 327 defined by the second outlet port 326” (0079),
“the second lumen 339 of the flow control mechanism 330, and the second outlet lumen 327 of the second outlet port 326 define a second fluid flow path that can place the external reservoir (not shown in FIG. 15) in fluid communication with the inlet port 322 and, therefore, the portion of the patient (e.g., the vein)… The negative pressure within the external reservoir… introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir 370” (0080); and
a housing 301 that fully encloses the inlet port, the outlet port 324, 326, the chamber 338, and the sampling channel 339, best seen in Figure 12-13 (0070),
wherein the chamber 338 and the sampling channel 339 have a fixed relationship with the housing during the collecting, as shown in Figure 14, and the bypassing, as shown in Figure 14 – “the flow control mechanism 330 moves concurrently with the actuator 340 when the actuator 340 is rotated relative to the housing 301. In this manner, the flow control mechanism 330 can be moved relative to the diverter 320 to place the first lumen 338 or the second lumen 339 in fluid communication with the inlet port 322, the first outlet port 324, and/or the second outlet port 326” (0072). In other words, after the pathway is selected, the chamber or sampling channel have a fixed relationship with the housing during the collecting and the bypassing.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Patent such that the chamber is connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, and the chamber has a fixed length during collection of the first portion of the blood sample as taught by Bullington et al in the manner above as an effective configuration for the desired blood flow and subsequent collection.
Claim 1 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 16 of U.S. Patent No. 11963769 in view of Bullington et al (US Pub No. 20140039348 – cited by applicant).
The Patent discloses an inlet port for receiving a bodily fluid that is capable of being a blood sample; an outlet port; a chamber connected at the inlet port and configured to collect a first portion of the blood sample, the chamber including a material that is air permeable and blood impermeable/air permeable blood barrier; a sampling channel connected with the inlet port and the outlet port and configured to convey a subsequent portion of the blood sample to the outlet port while bypassing the chamber; and a housing that defines the inlet port, the outlet port, the chamber, and the sampling channel.
However, the Patent does not expressly disclose the chamber connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, nor the chamber has a fixed length during collection of the first portion of the blood sample.
Bullington et al discloses an analogous device 300 comprising:
an inlet port 322 for receiving a blood sample, best seen in Figure 13-15 – “inlet port 322 is further configured to be fluidically coupled to a medical device (not shown) defining a fluid flow pathway for withdrawing and/or conveying the bodily-fluid from a patient to the transfer device 300… the inlet port 322 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) as described above” (0068, 0073);
an outlet port 326, best seen in Figure 13-15 – “second outlet port 326 of the diverter 320 defines a second outlet lumen 327 and is configured to be coupled to an external fluid reservoir” (0085), wherein the outlet port is also defined by 324, best seen in Figure 13-15 – “first outlet port 324 of the diverter 320 defines a first outlet lumen 325” (0069);
a chamber 338 (first lumen) connected at a proximal end with the inlet port, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330… define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
at a distal end with the outlet port portion 325 as defined above, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330, and the first outlet lumen 325 of the first outlet port 324 define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
the chamber leads to fluid reservoir 370 configured to collect a first portion of the blood sample, best seen in Figure 14 – “with the inlet port 322 coupled to the lumen-defining device, the first fluid flow path places the fluid reservoir 370 in fluid communication with the portion of the patient (e.g., the vein) and at least a portion of the suction force (e.g., applied by the negative pressure differential, as described above) is introduced to the portion of the patient. Thus, a bodily-fluid can be drawn into the fluid reservoir 370” (0076),
wherein the chamber has a fixed length during collection of the first portion of the blood sample, best seen in Figure 14; and
a sampling channel 339 (second lumen) connected with the inlet port and outlet port portion 326 as defined above, best seen in Figure 13-15, and
configured to convey a subsequent portion of the blood sample through the sampling channel to the outlet port while bypassing the chamber 338, best seen in Figure 15 – “the first lumen 338 is fluidically isolated from the inlet lumen 323 and the first outlet lumen 325, and the second lumen 339 is placed in fluid communication with the inlet lumen 323 defined by the inlet port 322 and the second outlet lumen 327 defined by the second outlet port 326” (0079),
“the second lumen 339 of the flow control mechanism 330, and the second outlet lumen 327 of the second outlet port 326 define a second fluid flow path that can place the external reservoir (not shown in FIG. 15) in fluid communication with the inlet port 322 and, therefore, the portion of the patient (e.g., the vein)… The negative pressure within the external reservoir… introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir 370” (0080); and
a housing 301 that fully encloses the inlet port, the outlet port 324, 326, the chamber 338, and the sampling channel 339, best seen in Figure 12-13 (0070),
wherein the chamber 338 and the sampling channel 339 have a fixed relationship with the housing during the collecting, as shown in Figure 14, and the bypassing, as shown in Figure 14 – “the flow control mechanism 330 moves concurrently with the actuator 340 when the actuator 340 is rotated relative to the housing 301. In this manner, the flow control mechanism 330 can be moved relative to the diverter 320 to place the first lumen 338 or the second lumen 339 in fluid communication with the inlet port 322, the first outlet port 324, and/or the second outlet port 326” (0072). In other words, after the pathway is selected, the chamber or sampling channel have a fixed relationship with the housing during the collecting and the bypassing.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Patent such that the chamber is connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, and the chamber has a fixed length during collection of the first portion of the blood sample as taught by Bullington et al in the manner above as an effective configuration for the desired blood flow and subsequent collection.
Claim 1 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13-14 of U.S. Patent No. 11832944 in view of Bullington et al (US Pub No. 20140039348 – cited by applicant).
The Patent discloses an inlet port for receiving a blood sample; an outlet port; a chamber connected at the inlet port and configured to collect a first portion of the blood sample, the chamber including a material that is air permeable and blood impermeable/air permeable blood barrier; a sampling channel connected with the inlet port and the outlet port and configured to convey a subsequent portion of the blood sample to the outlet port while bypassing the chamber; and a housing that defines the inlet port, the outlet port, the chamber, and the sampling channel.
However, the Patent does not expressly disclose the chamber connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, nor the chamber has a fixed length during collection of the first portion of the blood sample.
Bullington et al discloses an analogous device 300 comprising:
an inlet port 322 for receiving a blood sample, best seen in Figure 13-15 – “inlet port 322 is further configured to be fluidically coupled to a medical device (not shown) defining a fluid flow pathway for withdrawing and/or conveying the bodily-fluid from a patient to the transfer device 300… the inlet port 322 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) as described above” (0068, 0073);
an outlet port 326, best seen in Figure 13-15 – “second outlet port 326 of the diverter 320 defines a second outlet lumen 327 and is configured to be coupled to an external fluid reservoir” (0085), wherein the outlet port is also defined by 324, best seen in Figure 13-15 – “first outlet port 324 of the diverter 320 defines a first outlet lumen 325” (0069);
a chamber 338 (first lumen) connected at a proximal end with the inlet port, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330… define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
at a distal end with the outlet port portion 325 as defined above, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330, and the first outlet lumen 325 of the first outlet port 324 define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
the chamber leads to fluid reservoir 370 configured to collect a first portion of the blood sample, best seen in Figure 14 – “with the inlet port 322 coupled to the lumen-defining device, the first fluid flow path places the fluid reservoir 370 in fluid communication with the portion of the patient (e.g., the vein) and at least a portion of the suction force (e.g., applied by the negative pressure differential, as described above) is introduced to the portion of the patient. Thus, a bodily-fluid can be drawn into the fluid reservoir 370” (0076),
wherein the chamber has a fixed length during collection of the first portion of the blood sample, best seen in Figure 14; and
a sampling channel 339 (second lumen) connected with the inlet port and outlet port portion 326 as defined above, best seen in Figure 13-15, and
configured to convey a subsequent portion of the blood sample through the sampling channel to the outlet port while bypassing the chamber 338, best seen in Figure 15 – “the first lumen 338 is fluidically isolated from the inlet lumen 323 and the first outlet lumen 325, and the second lumen 339 is placed in fluid communication with the inlet lumen 323 defined by the inlet port 322 and the second outlet lumen 327 defined by the second outlet port 326” (0079),
“the second lumen 339 of the flow control mechanism 330, and the second outlet lumen 327 of the second outlet port 326 define a second fluid flow path that can place the external reservoir (not shown in FIG. 15) in fluid communication with the inlet port 322 and, therefore, the portion of the patient (e.g., the vein)… The negative pressure within the external reservoir… introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir 370” (0080); and
a housing 301 that fully encloses the inlet port, the outlet port 324, 326, the chamber 338, and the sampling channel 339, best seen in Figure 12-13 (0070),
wherein the chamber 338 and the sampling channel 339 have a fixed relationship with the housing during the collecting, as shown in Figure 14, and the bypassing, as shown in Figure 14 – “the flow control mechanism 330 moves concurrently with the actuator 340 when the actuator 340 is rotated relative to the housing 301. In this manner, the flow control mechanism 330 can be moved relative to the diverter 320 to place the first lumen 338 or the second lumen 339 in fluid communication with the inlet port 322, the first outlet port 324, and/or the second outlet port 326” (0072). In other words, after the pathway is selected, the chamber or sampling channel have a fixed relationship with the housing during the collecting and the bypassing.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Patent such that the chamber is connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, and the chamber has a fixed length during collection of the first portion of the blood sample as taught by Bullington et al in the manner above as an effective configuration for the desired blood flow and subsequent collection.
Claim 1 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 16 of U.S. Patent No. 11185266 in view of Bullington et al (US Pub No. 20140039348 – cited by applicant).
The Patent discloses an inlet port for receiving a bodily fluid capable of being a blood sample; an outlet port; a chamber connected at the inlet port and configured to collect a first portion of the blood sample, the chamber including a material that is air permeable and blood impermeable/air permeable blood barrier; a sampling channel connected with the inlet port and the outlet port and configured to convey a subsequent portion of the blood sample to the outlet port while bypassing the chamber; and a housing that defines the inlet port, the outlet port, the chamber, and the sampling channel.
However, the Patent does not expressly disclose the chamber connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, nor the chamber has a fixed length during collection of the first portion of the blood sample.
Bullington et al discloses an analogous device 300 comprising:
an inlet port 322 for receiving a blood sample, best seen in Figure 13-15 – “inlet port 322 is further configured to be fluidically coupled to a medical device (not shown) defining a fluid flow pathway for withdrawing and/or conveying the bodily-fluid from a patient to the transfer device 300… the inlet port 322 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) as described above” (0068, 0073);
an outlet port 326, best seen in Figure 13-15 – “second outlet port 326 of the diverter 320 defines a second outlet lumen 327 and is configured to be coupled to an external fluid reservoir” (0085), wherein the outlet port is also defined by 324, best seen in Figure 13-15 – “first outlet port 324 of the diverter 320 defines a first outlet lumen 325” (0069);
a chamber 338 (first lumen) connected at a proximal end with the inlet port, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330… define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
at a distal end with the outlet port portion 325 as defined above, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330, and the first outlet lumen 325 of the first outlet port 324 define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
the chamber leads to fluid reservoir 370 configured to collect a first portion of the blood sample, best seen in Figure 14 – “with the inlet port 322 coupled to the lumen-defining device, the first fluid flow path places the fluid reservoir 370 in fluid communication with the portion of the patient (e.g., the vein) and at least a portion of the suction force (e.g., applied by the negative pressure differential, as described above) is introduced to the portion of the patient. Thus, a bodily-fluid can be drawn into the fluid reservoir 370” (0076),
wherein the chamber has a fixed length during collection of the first portion of the blood sample, best seen in Figure 14; and
a sampling channel 339 (second lumen) connected with the inlet port and outlet port portion 326 as defined above, best seen in Figure 13-15, and
configured to convey a subsequent portion of the blood sample through the sampling channel to the outlet port while bypassing the chamber 338, best seen in Figure 15 – “the first lumen 338 is fluidically isolated from the inlet lumen 323 and the first outlet lumen 325, and the second lumen 339 is placed in fluid communication with the inlet lumen 323 defined by the inlet port 322 and the second outlet lumen 327 defined by the second outlet port 326” (0079),
“the second lumen 339 of the flow control mechanism 330, and the second outlet lumen 327 of the second outlet port 326 define a second fluid flow path that can place the external reservoir (not shown in FIG. 15) in fluid communication with the inlet port 322 and, therefore, the portion of the patient (e.g., the vein)… The negative pressure within the external reservoir… introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir 370” (0080); and
a housing 301 that fully encloses the inlet port, the outlet port 324, 326, the chamber 338, and the sampling channel 339, best seen in Figure 12-13 (0070),
wherein the chamber 338 and the sampling channel 339 have a fixed relationship with the housing during the collecting, as shown in Figure 14, and the bypassing, as shown in Figure 14 – “the flow control mechanism 330 moves concurrently with the actuator 340 when the actuator 340 is rotated relative to the housing 301. In this manner, the flow control mechanism 330 can be moved relative to the diverter 320 to place the first lumen 338 or the second lumen 339 in fluid communication with the inlet port 322, the first outlet port 324, and/or the second outlet port 326” (0072). In other words, after the pathway is selected, the chamber or sampling channel have a fixed relationship with the housing during the collecting and the bypassing.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Patent such that the chamber is connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, and the chamber has a fixed length during collection of the first portion of the blood sample as taught by Bullington et al in the manner above as an effective configuration for the desired blood flow and subsequent collection.
Claim 1 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 10143412 in view of Bullington et al (US Pub No. 20140039348 – cited by applicant).
The Patent discloses an inlet port for receiving a blood sample; an outlet port; a chamber connected at the inlet port and configured to collect a first portion of the blood sample, the chamber including a material that is air permeable and blood impermeable/air permeable blood barrier; a sampling channel connected with the inlet port and the outlet port and configured to convey a subsequent portion of the blood sample to the outlet port while bypassing the chamber; and a housing that defines the inlet port, the outlet port, the chamber, and the sampling channel.
However, the Patent does not expressly disclose the chamber connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, nor the chamber has a fixed length during collection of the first portion of the blood sample.
Bullington et al discloses an analogous device 300 comprising:
an inlet port 322 for receiving a blood sample, best seen in Figure 13-15 – “inlet port 322 is further configured to be fluidically coupled to a medical device (not shown) defining a fluid flow pathway for withdrawing and/or conveying the bodily-fluid from a patient to the transfer device 300… the inlet port 322 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) as described above” (0068, 0073);
an outlet port 326, best seen in Figure 13-15 – “second outlet port 326 of the diverter 320 defines a second outlet lumen 327 and is configured to be coupled to an external fluid reservoir” (0085), wherein the outlet port is also defined by 324, best seen in Figure 13-15 – “first outlet port 324 of the diverter 320 defines a first outlet lumen 325” (0069);
a chamber 338 (first lumen) connected at a proximal end with the inlet port, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330… define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
at a distal end with the outlet port portion 325 as defined above, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330, and the first outlet lumen 325 of the first outlet port 324 define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
the chamber leads to fluid reservoir 370 configured to collect a first portion of the blood sample, best seen in Figure 14 – “with the inlet port 322 coupled to the lumen-defining device, the first fluid flow path places the fluid reservoir 370 in fluid communication with the portion of the patient (e.g., the vein) and at least a portion of the suction force (e.g., applied by the negative pressure differential, as described above) is introduced to the portion of the patient. Thus, a bodily-fluid can be drawn into the fluid reservoir 370” (0076),
wherein the chamber has a fixed length during collection of the first portion of the blood sample, best seen in Figure 14; and
a sampling channel 339 (second lumen) connected with the inlet port and outlet port portion 326 as defined above, best seen in Figure 13-15, and
configured to convey a subsequent portion of the blood sample through the sampling channel to the outlet port while bypassing the chamber 338, best seen in Figure 15 – “the first lumen 338 is fluidically isolated from the inlet lumen 323 and the first outlet lumen 325, and the second lumen 339 is placed in fluid communication with the inlet lumen 323 defined by the inlet port 322 and the second outlet lumen 327 defined by the second outlet port 326” (0079),
“the second lumen 339 of the flow control mechanism 330, and the second outlet lumen 327 of the second outlet port 326 define a second fluid flow path that can place the external reservoir (not shown in FIG. 15) in fluid communication with the inlet port 322 and, therefore, the portion of the patient (e.g., the vein)… The negative pressure within the external reservoir… introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir 370” (0080); and
a housing 301 that fully encloses the inlet port, the outlet port 324, 326, the chamber 338, and the sampling channel 339, best seen in Figure 12-13 (0070),
wherein the chamber 338 and the sampling channel 339 have a fixed relationship with the housing during the collecting, as shown in Figure 14, and the bypassing, as shown in Figure 14 – “the flow control mechanism 330 moves concurrently with the actuator 340 when the actuator 340 is rotated relative to the housing 301. In this manner, the flow control mechanism 330 can be moved relative to the diverter 320 to place the first lumen 338 or the second lumen 339 in fluid communication with the inlet port 322, the first outlet port 324, and/or the second outlet port 326” (0072). In other words, after the pathway is selected, the chamber or sampling channel have a fixed relationship with the housing during the collecting and the bypassing.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Patent such that the chamber is connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, and the chamber has a fixed length during collection of the first portion of the blood sample as taught by Bullington et al in the manner above as an effective configuration for the desired blood flow and subsequent collection.
Claim 1 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10010282 in view of Bullington et al (US Pub No. 20140039348 – cited by applicant).
The Patent discloses an inlet port for receiving a blood sample; an outlet port; a chamber connected at the inlet port and configured to collect a first portion of the blood sample, the chamber including a material that is air permeable and blood impermeable/air permeable blood barrier; a sampling channel connected with the inlet port and the outlet port and configured to convey a subsequent portion of the blood sample to the outlet port while bypassing the chamber; and a housing that defines the inlet port, the outlet port, the chamber, and the sampling channel.
However, the Patent does not expressly disclose the chamber connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, nor the chamber has a fixed length during collection of the first portion of the blood sample.
Bullington et al discloses an analogous device 300 comprising:
an inlet port 322 for receiving a blood sample, best seen in Figure 13-15 – “inlet port 322 is further configured to be fluidically coupled to a medical device (not shown) defining a fluid flow pathway for withdrawing and/or conveying the bodily-fluid from a patient to the transfer device 300… the inlet port 322 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) as described above” (0068, 0073);
an outlet port 326, best seen in Figure 13-15 – “second outlet port 326 of the diverter 320 defines a second outlet lumen 327 and is configured to be coupled to an external fluid reservoir” (0085), wherein the outlet port is also defined by 324, best seen in Figure 13-15 – “first outlet port 324 of the diverter 320 defines a first outlet lumen 325” (0069);
a chamber 338 (first lumen) connected at a proximal end with the inlet port, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330… define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
at a distal end with the outlet port portion 325 as defined above, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330, and the first outlet lumen 325 of the first outlet port 324 define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
the chamber leads to fluid reservoir 370 configured to collect a first portion of the blood sample, best seen in Figure 14 – “with the inlet port 322 coupled to the lumen-defining device, the first fluid flow path places the fluid reservoir 370 in fluid communication with the portion of the patient (e.g., the vein) and at least a portion of the suction force (e.g., applied by the negative pressure differential, as described above) is introduced to the portion of the patient. Thus, a bodily-fluid can be drawn into the fluid reservoir 370” (0076),
wherein the chamber has a fixed length during collection of the first portion of the blood sample, best seen in Figure 14; and
a sampling channel 339 (second lumen) connected with the inlet port and outlet port portion 326 as defined above, best seen in Figure 13-15, and
configured to convey a subsequent portion of the blood sample through the sampling channel to the outlet port while bypassing the chamber 338, best seen in Figure 15 – “the first lumen 338 is fluidically isolated from the inlet lumen 323 and the first outlet lumen 325, and the second lumen 339 is placed in fluid communication with the inlet lumen 323 defined by the inlet port 322 and the second outlet lumen 327 defined by the second outlet port 326” (0079),
“the second lumen 339 of the flow control mechanism 330, and the second outlet lumen 327 of the second outlet port 326 define a second fluid flow path that can place the external reservoir (not shown in FIG. 15) in fluid communication with the inlet port 322 and, therefore, the portion of the patient (e.g., the vein)… The negative pressure within the external reservoir… introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir 370” (0080); and
a housing 301 that fully encloses the inlet port, the outlet port 324, 326, the chamber 338, and the sampling channel 339, best seen in Figure 12-13 (0070),
wherein the chamber 338 and the sampling channel 339 have a fixed relationship with the housing during the collecting, as shown in Figure 14, and the bypassing, as shown in Figure 14 – “the flow control mechanism 330 moves concurrently with the actuator 340 when the actuator 340 is rotated relative to the housing 301. In this manner, the flow control mechanism 330 can be moved relative to the diverter 320 to place the first lumen 338 or the second lumen 339 in fluid communication with the inlet port 322, the first outlet port 324, and/or the second outlet port 326” (0072). In other words, after the pathway is selected, the chamber or sampling channel have a fixed relationship with the housing during the collecting and the bypassing.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Patent such that the chamber is connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, and the chamber has a fixed length during collection of the first portion of the blood sample as taught by Bullington et al in the manner above as an effective configuration for the desired blood flow and subsequent collection.
Claim 1 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-14 of U.S. Patent No. 12138052 in view of Bullington et al (US Pub No. 20140039348 – cited by applicant) and Andersen (US Pat No. 4519402).
The Patent discloses an inlet port for receiving a blood sample; an outlet port; a chamber connected at the inlet port and configured to collect a first portion of the blood sample, the chamber including a material that blood impermeable/blood barrier; a sampling channel connected with the inlet port and the outlet port and configured to convey a subsequent portion of the blood sample to the outlet port while bypassing the chamber; and a housing that defines the inlet port, the outlet port, and the sampling channel.
However, the Patent does not expressly disclose the chamber connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, the chamber has a fixed length during collection of the first portion of the blood sample, nor the blood impermeable material is air permeable.
Bullington et al discloses an analogous device 300 comprising:
an inlet port 322 for receiving a blood sample, best seen in Figure 13-15 – “inlet port 322 is further configured to be fluidically coupled to a medical device (not shown) defining a fluid flow pathway for withdrawing and/or conveying the bodily-fluid from a patient to the transfer device 300… the inlet port 322 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) as described above” (0068, 0073);
an outlet port 326, best seen in Figure 13-15 – “second outlet port 326 of the diverter 320 defines a second outlet lumen 327 and is configured to be coupled to an external fluid reservoir” (0085), wherein the outlet port is also defined by 324, best seen in Figure 13-15 – “first outlet port 324 of the diverter 320 defines a first outlet lumen 325” (0069);
a chamber 338 (first lumen) connected at a proximal end with the inlet port, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330… define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
at a distal end with the outlet port portion 325 as defined above, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330, and the first outlet lumen 325 of the first outlet port 324 define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
the chamber leads to fluid reservoir 370 configured to collect a first portion of the blood sample, best seen in Figure 14 – “with the inlet port 322 coupled to the lumen-defining device, the first fluid flow path places the fluid reservoir 370 in fluid communication with the portion of the patient (e.g., the vein) and at least a portion of the suction force (e.g., applied by the negative pressure differential, as described above) is introduced to the portion of the patient. Thus, a bodily-fluid can be drawn into the fluid reservoir 370” (0076),
wherein the chamber has a fixed length during collection of the first portion of the blood sample, best seen in Figure 14; and
a sampling channel 339 (second lumen) connected with the inlet port and outlet port portion 326 as defined above, best seen in Figure 13-15, and
configured to convey a subsequent portion of the blood sample through the sampling channel to the outlet port while bypassing the chamber 338, best seen in Figure 15 – “the first lumen 338 is fluidically isolated from the inlet lumen 323 and the first outlet lumen 325, and the second lumen 339 is placed in fluid communication with the inlet lumen 323 defined by the inlet port 322 and the second outlet lumen 327 defined by the second outlet port 326” (0079),
“the second lumen 339 of the flow control mechanism 330, and the second outlet lumen 327 of the second outlet port 326 define a second fluid flow path that can place the external reservoir (not shown in FIG. 15) in fluid communication with the inlet port 322 and, therefore, the portion of the patient (e.g., the vein)… The negative pressure within the external reservoir… introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir 370” (0080); and
a housing 301 that fully encloses the inlet port, the outlet port 324, 326, the chamber 338, and the sampling channel 339, best seen in Figure 12-13 (0070),
wherein the chamber 338 and the sampling channel 339 have a fixed relationship with the housing during the collecting, as shown in Figure 14, and the bypassing, as shown in Figure 14 – “the flow control mechanism 330 moves concurrently with the actuator 340 when the actuator 340 is rotated relative to the housing 301. In this manner, the flow control mechanism 330 can be moved relative to the diverter 320 to place the first lumen 338 or the second lumen 339 in fluid communication with the inlet port 322, the first outlet port 324, and/or the second outlet port 326” (0072). In other words, after the pathway is selected, the chamber or sampling channel have a fixed relationship with the housing during the collecting and the bypassing.
Andersen disclose air permeable material in an analogous device to allow air to escape as necessary (abst).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Patent such that the chamber is connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, and the chamber has a fixed length during collection of the first portion of the blood sample as taught by Bullington et al in the manner above as an effective configuration for the desired blood flow and subsequent collection.
Therefore, it would have been obvious to one of ordinary skill in art at the time of filing to modify the Patent such that the blood impermeable material is air permeable as taught by Andersen et al to effectively allow air to escape as necessary.
Claim 1 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11311219 in view of Bullington et al (US Pub No. 20140039348 – cited by applicant).
The Patent discloses an inlet port for receiving a blood sample; an outlet port; a chamber connected at the inlet port and configured to collect a first portion of the blood sample, the chamber including a material that air permeable and blood impermeable/air permeable blood barrier; a sampling channel connected with the inlet port and the outlet port and configured to convey a subsequent portion of the blood sample to the outlet port while bypassing the chamber; and a housing that defines the inlet port, the outlet port, and the sampling channel.
However, the Patent does not expressly disclose the chamber connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, nor the chamber has a fixed length during collection of the first portion of the blood sample.
Bullington et al discloses an analogous device 300 comprising:
an inlet port 322 for receiving a blood sample, best seen in Figure 13-15 – “inlet port 322 is further configured to be fluidically coupled to a medical device (not shown) defining a fluid flow pathway for withdrawing and/or conveying the bodily-fluid from a patient to the transfer device 300… the inlet port 322 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) as described above” (0068, 0073);
an outlet port 326, best seen in Figure 13-15 – “second outlet port 326 of the diverter 320 defines a second outlet lumen 327 and is configured to be coupled to an external fluid reservoir” (0085), wherein the outlet port is also defined by 324, best seen in Figure 13-15 – “first outlet port 324 of the diverter 320 defines a first outlet lumen 325” (0069);
a chamber 338 (first lumen) connected at a proximal end with the inlet port, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330… define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
at a distal end with the outlet port portion 325 as defined above, best seen in Figure 13-14 – “As shown by the arrow JJ, the inlet lumen 323 of the inlet port 322, the first lumen 338 of the flow control mechanism 330, and the first outlet lumen 325 of the first outlet port 324 define a first fluid flow path that places the inner volume 373 defined by the fluid reservoir 370 in fluid communication with the inlet port 322” (0076),
the chamber leads to fluid reservoir 370 configured to collect a first portion of the blood sample, best seen in Figure 14 – “with the inlet port 322 coupled to the lumen-defining device, the first fluid flow path places the fluid reservoir 370 in fluid communication with the portion of the patient (e.g., the vein) and at least a portion of the suction force (e.g., applied by the negative pressure differential, as described above) is introduced to the portion of the patient. Thus, a bodily-fluid can be drawn into the fluid reservoir 370” (0076),
wherein the chamber has a fixed length during collection of the first portion of the blood sample, best seen in Figure 14; and
a sampling channel 339 (second lumen) connected with the inlet port and outlet port portion 326 as defined above, best seen in Figure 13-15, and
configured to convey a subsequent portion of the blood sample through the sampling channel to the outlet port while bypassing the chamber 338, best seen in Figure 15 – “the first lumen 338 is fluidically isolated from the inlet lumen 323 and the first outlet lumen 325, and the second lumen 339 is placed in fluid communication with the inlet lumen 323 defined by the inlet port 322 and the second outlet lumen 327 defined by the second outlet port 326” (0079),
“the second lumen 339 of the flow control mechanism 330, and the second outlet lumen 327 of the second outlet port 326 define a second fluid flow path that can place the external reservoir (not shown in FIG. 15) in fluid communication with the inlet port 322 and, therefore, the portion of the patient (e.g., the vein) … The negative pressure within the external reservoir… introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir 370” (0080); and
a housing 301 that fully encloses the inlet port, the outlet port 324, 326, the chamber 338, and the sampling channel 339, best seen in Figure 12-13 (0070),
wherein the chamber 338 and the sampling channel 339 have a fixed relationship with the housing during the collecting, as shown in Figure 14, and the bypassing, as shown in Figure 14 – “the flow control mechanism 330 moves concurrently with the actuator 340 when the actuator 340 is rotated relative to the housing 301. In this manner, the flow control mechanism 330 can be moved relative to the diverter 320 to place the first lumen 338 or the second lumen 339 in fluid communication with the inlet port 322, the first outlet port 324, and/or the second outlet port 326” (0072). In other words, after the pathway is selected, the chamber or sampling channel have a fixed relationship with the housing during the collecting and the bypassing.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Patent such that the chamber is connected at a proximal end with the inlet port and at a distal end with the outlet port, the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, and the chamber has a fixed length during collection of the first portion of the blood sample as taught by Bullington et al in the manner above as an effective configuration for the desired blood flow and subsequent collection.
Response to Arguments
Applicant’s arguments with respect to claim(s) above 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. Bullington et al (20140039348) has been set forth in the manner above.
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 Huong NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791
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