DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/6/2026 has been entered.
Claims 1-2, 6, and 34-36 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, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over
Bullington et al (US Pub No. 20140163419 – cited by applicant) in view of Andersen (US Pat No. 4519402).
In regard to Claims 1 and 34, Bullington et al discloses a device comprising:
an inlet port 405 for receiving a blood sample, best seen in Figure 12 (0081, 0089);
an outlet port 402 (proximal end portion of housing 401), best seen in Figure 13-15 (0085);
a chamber 480 connected at a proximal end with the inlet port, best seen in Figure 13-14, and
at a distal end with the outlet port (reservoir 480 leads to end of housing 401, which is defined as the outlet port above), best seen in Figure 14, and
configured to collect a first portion of the blood sample – “the proximal motion of the second member 451 moves the plunger 476 of the first member 470 in the proximal direction relative to the shunt tube 471… increases the volume of the portion of the inner volume 411 of the housing 401 that is distal of the plunger 476, thereby defining the first reservoir 480, as shown in FIG. 14. With the plunger 476 forming a fluid tight seal with the inner surface of the walls defining the inner volume 411 and with the shunt tube 471 about which the plunger 476 is disposed, the volume increase of the portion of the inner volume 411 can produce a negative pressure within the first reservoir 480” (0079, 0091); “Thus, a bodily-fluid is drawn through the port 405, the first lumen 432 defined by the flow control mechanism 430, and the first lumen 406 defined by the diverter 409 and into the fluid reservoir 480” (0092);
a sampling channel 433 (second lumen) connected with the inlet port and outlet port and configured to convey a subsequent portion of the blood sample through the sampling channel to the outlet port while bypassing the chamber – moving member 435 rotates first member 431 such that lumen 433 is aligned with inlet port 405 such that “a desired amount of bodily-fluid is drawn through the port 405, the second lumen 433 of the flow control mechanism 430, the second lumen 407 of the diverter 409, and the lumen 475 defined by the shunt tube 471 and into the second reservoir 490. Moreover, the bodily-fluid disposed within the second reservoir 490 is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the first reservoir 480” (0082, 0083, 0095, 0097); and
a housing 401 that fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, best seen in Figure 12 and 14,
wherein the chamber and the sampling channel have a fixed relationship with the housing during the collecting and the bypassing, best seen in Figure 12-15.
However, Bullington et al do not expressly disclose the chamber including a material that is air permeable and blood impermeable/air permeable blood barrier.
Andersen teach that it is well-known in the art to provide an analogous device (syringe) comprising a blood barrier disposed in the housing between the chamber and the outlet, the blood barrier being gas permeable (pervious to gas) and blood impermeable (impervious to liquid) to enable venting of gas as well as automatic stopping of the flow of blood into the chamber because “the flow of blood into the syringe is automatically stopped when the sample collecting chamber of the syringe has been filled, because blood cannot pass the liquid impervious material arranged in the recesses” (abst).
“When a blood sample is to be collected from an artery, the piston 106 is positioned in such an axial position that the volume of the blood collecting chamber 108 substantially corresponds to the desired volume of the blood sample, and in that position the piston sealing ring 107 must be in engagement with the gas pervious material arranged in the recesses 102. The pointed free end of the hollow needle 110 is now inserted into an artery so that arterial blood may flow through the needle 110 and into the chamber 108 under the arterial blood pressure. Gas or air may then escape from the blood collecting chamber 108 through a venting passage formed by a space 103 defined between the peripheral outer wall of the piston 106 and the inner wall of the syringe cylinder 101 and by the gas pervious material arranged within the recess or recesses 102. When all of the air has been expelled from the chamber 108 and blood has penetrated into the space 103 up to the sealing ring 107, further progress of the blood is stopped, because gas, but not blood, can pass through the hydrophobic material in the recesses, and the hollow needle may now be removed from the artery” (Col.4: 1-19).
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 such as placed at the distal end of the chamber near the plunger to effectively enable venting of gas as well as automatic stopping of the flow of blood into the chamber as taught by Andersen.
2, 35. Andersen teach the material is configured to seal upon contact with the first portion of the blood sample (abst).
6, 36. Bullington et al disclose the device is configured with a moving part 430, 431, 435 (flow control mechanism first member 431 controlled by member 435) that is movable from a first position, best seen in Figure 13-14 – “the proximal motion of the second member 451 moves the plunger 476 of the first member 470 in the proximal direction relative to the shunt tube 471… increases the volume of the portion of the inner volume 411 of the housing 401 that is distal of the plunger 476, thereby defining the first reservoir 480, as shown in FIG. 14. With the plunger 476 forming a fluid tight seal with the inner surface of the walls defining the inner volume 411 and with the shunt tube 471 about which the plunger 476 is disposed, the volume increase of the portion of the inner volume 411 can produce a negative pressure within the first reservoir 480” (0079, 0091); “Thus, a bodily-fluid is drawn through the port 405, the first lumen 432 defined by the flow control mechanism 430, and the first lumen 406 defined by the diverter 409 and into the fluid reservoir 480” (0092),
to a second position, best seen in Figure 14-15, to allow blood to bypass the chamber 480 and go through the sampling channel 433 – moving member 435 rotates first member 431 such that lumen 433 is aligned with inlet port 405 such that “a desired amount of bodily-fluid is drawn through the port 405, the second lumen 433 of the flow control mechanism 430, the second lumen 407 of the diverter 409, and the lumen 475 defined by the shunt tube 471 and into the second reservoir 490. Moreover, the bodily-fluid disposed within the second reservoir 490 is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the first reservoir 480” (0082, 0083, 0095, 0097).
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. 20140163419).
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.
Bullington et al disclose a chamber 480 connected at a proximal end with the inlet port 402, best seen in Figure 13-14, and at a distal end with the outlet port (reservoir 480 leads to end of housing 401, which is defined as the outlet port, best seen in Figure 14, as an effective configuration to connect to the chamber to the rest of the device for the desired fluid flow.
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 taught by Bullington et al as an effective configuration for the desired fluid flow.
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. 20140163419).
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, nor the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel.
Bullington et al disclose an analogous device comprising chamber 480 connected at a proximal end with the inlet port 402, best seen in Figure 13-14, and at a distal end with the outlet port (reservoir 480 leads to end of housing 401, which is defined as the outlet port, best seen in Figure 14, as an effective configuration to connect to the chamber to the rest of the device for the desired fluid flow.
Bullington et al disclose a housing 401 that fully encloses the inlet port 402, the outlet port 401, the chamber 480, and the sampling channel 433, best seen in Figure 12 and 14.
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 housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel as taught by Burlington et al as an effective configuration for the desired fluid flow.
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. 20140163419).
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, nor the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel.
Bullington et al disclose an analogous device comprising a chamber 480 connected at a proximal end with the inlet port 402, best seen in Figure 13-14, and at a distal end with the outlet port (reservoir 480 leads to end of housing 401, which is defined as the outlet port, best seen in Figure 14, as an effective configuration to connect to the chamber to the rest of the device for the desired fluid flow.
Bullington et al disclose a housing 401 that fully encloses the inlet port 402, the outlet port 401, the chamber 480, and the sampling channel 433, best seen in Figure 12 and 14.
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 housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel as taught by Bullington et al as an effective configuration for the desired fluid flow.
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. 20140163419).
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, nor the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel.
Bullington et al disclose an analogous device comprising a chamber 480 connected at a proximal end with the inlet port 402, best seen in Figure 13-14, and at a distal end with the outlet port (reservoir 480 leads to end of housing 401, which is defined as the outlet port, best seen in Figure 14, as an effective configuration to connect to the chamber to the rest of the device for the desired fluid flow.
Bullington et al disclose a housing 401 that fully encloses the inlet port 402, the outlet port 401, the chamber 480, and the sampling channel 433, best seen in Figure 12 and 14.
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 housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel as taught by Bullington et al as an effective configuration for the desired fluid flow.
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. 20140163419).
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, nor the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel.
Bullington et al disclose an analogous device comprising a chamber 480 connected at a proximal end with the inlet port 402, best seen in Figure 13-14, and at a distal end with the outlet port (reservoir 480 leads to end of housing 401, which is defined as the outlet port, best seen in Figure 14, as an effective configuration to connect to the chamber to the rest of the device for the desired fluid flow.
Bullington et al disclose a housing 401 that fully encloses the inlet port 402, the outlet port 401, the chamber 480, and the sampling channel 433, best seen in Figure 12 and 14.
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 housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel as taught by Bullington et al as an effective configuration for the desired fluid flow.
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. 20140163419).
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, nor the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel.
Bullington et al disclose an analogous device comprising a chamber 480 connected at a proximal end with the inlet port 402, best seen in Figure 13-14, and at a distal end with the outlet port (reservoir 480 leads to end of housing 401, which is defined as the outlet port, best seen in Figure 14, as an effective configuration to connect to the chamber to the rest of the device for the desired fluid flow.
Bullington et al disclose a housing 401 that fully encloses the inlet port 402, the outlet port 401, the chamber 480, and the sampling channel 433, best seen in Figure 12 and 14.
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 housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel as taught by Bullington et al as an effective configuration for the desired fluid flow.
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. 20140163419).
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, nor the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel.
Bullington et al disclose an analogous device comprising a chamber 480 connected at a proximal end with the inlet port 402, best seen in Figure 13-14, and at a distal end with the outlet port (reservoir 480 leads to end of housing 401, which is defined as the outlet port, best seen in Figure 14, as an effective configuration to connect to the chamber to the rest of the device for the desired fluid flow.
Bullington et al disclose a housing 401 that fully encloses the inlet port 402, the outlet port 401, the chamber 480, and the sampling channel 433, best seen in Figure 12 and 14.
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 housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel as taught by Bullington et al as an effective configuration for the desired fluid flow.
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. 20140163419).
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, nor the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel.
Bullington et al disclose an analogous device comprising a chamber 480 connected at a proximal end with the inlet port 402, best seen in Figure 13-14, and at a distal end with the outlet port (reservoir 480 leads to end of housing 401, which is defined as the outlet port, best seen in Figure 14, as an effective configuration to connect to the chamber to the rest of the device for the desired fluid flow.
Bullington et al disclose a housing 401 that fully encloses the inlet port 402, the outlet port 401, the chamber 480, and the sampling channel 433, best seen in Figure 12 and 14.
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 housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel as taught by Bullington et al as an effective configuration for the desired fluid flow.
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. 20140163419).
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, nor the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel.
Bullington et al disclose an analogous device comprising a chamber 480 connected at a proximal end with the inlet port 402, best seen in Figure 13-14, and at a distal end with the outlet port (reservoir 480 leads to end of housing 401, which is defined as the outlet port, best seen in Figure 14, as an effective configuration to connect to the chamber to the rest of the device for the desired fluid flow.
Bullington et al disclose a housing 401 that fully encloses the inlet port 402, the outlet port 401, the chamber 480, and the sampling channel 433, best seen in Figure 12 and 14.
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 housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel as taught by Bullington et al as an effective configuration for the desired fluid flow.
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. 20140163419) 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, nor the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel, nor the blood impermeable material is air permeable.
Bullington et al disclose an analogous device comprising a chamber 480 connected at a proximal end with the inlet port 402, best seen in Figure 13-14, and at a distal end with the outlet port (reservoir 480 leads to end of housing 401, which is defined as the outlet port, best seen in Figure 14, as an effective configuration to connect to the chamber to the rest of the device for the desired fluid flow.
Bullington et al disclose a housing 401 that fully encloses the inlet port 402, the outlet port 401, the chamber 480, and the sampling channel 433, best seen in Figure 12 and 14.
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 as well as the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel as taught by Bullington et al as an effective configuration for the desired fluid flow. 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. 20140163419).
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, nor the housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel.
Bullington et al disclose an analogous device comprising a chamber 480 connected at a proximal end with the inlet port 402, best seen in Figure 13-14, and at a distal end with the outlet port (reservoir 480 leads to end of housing 401, which is defined as the outlet port, best seen in Figure 14, as an effective configuration to connect to the chamber to the rest of the device for the desired fluid flow.
Bullington et al disclose a housing 401 that fully encloses the inlet port 402, the outlet port 401, the chamber 480, and the sampling channel 433, best seen in Figure 12 and 14.
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 housing fully encloses the inlet port, the outlet port, the chamber, and the sampling channel as taught by Bullington et al as an effective configuration for the desired fluid flow.
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.
Conclusion
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791