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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/11/2026 has been entered.
Claims 2-11 and 13-23 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 claim elements are interpreted under 112(f).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2-3 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patton (US Pub No. 20080145933 – cited any applicant).
In regard to Claims 2, Patton disclose a device comprising:
an inlet port 514 – input tubing – for receiving a blood sample, best seen in Figure 5 and 7A-B (0038-0039, 0044-0046);
an outlet port 518 configured to be fluidically coupled to a separate blood sample collection device 506 (sample vessel), best seen in Figure 5-6 – “the blood flows into the one or more sample vessels (not shown) via the second sterile output tubing 518” (0042, 0040, 0038);
a chamber 504 (pre-sample reservoir) connected with the inlet port, best seen in Figure 5 and 7A-B, and
configured to collect a first portion of the blood sample – “the diversion mechanism 512 can be initially adjusted to divert blood to the one or more pre-sample reservoirs 504 until the one or more pre-sample reservoirs 504 are filled, or a desired amount of blood has been withdrawn, at which point the diversion mechanism 512 can be adjusted to divert the flow of blood to the one or more sample vessels 506” (0040),
the chamber 504 having a volume sufficient to collect the first portion of the blood sample that is more prone to contamination and also to minimize an amount of blood to be collected as broadly as has been claimed, best seen in Figure 5 – “Dermally-residing microbes which may have been dislodged into the lumen of the first needle 108 during the insertion of the first needle 108 into the vein 202 may be washed into the pre-sample reservoir 104, thereby reducing the microbial contamination in the blood that is subsequently used as one or more samples for cultured microbial tests” (0031)
a sampling channel 710 connected with the inlet port and configured to convey a subsequent portion of the blood sample (0040) to the outlet port 518, best seen in Figure 7B –
“flow of blood input from the flexible, sterile input tubing 514 passes through the lumen 706 of the input flow-control block 702 and through the second lumen 710 of the output flow-control block 704 and into the one or more sample vessels (not shown) via the second sterile output tubing 518” (0046).
3. The device, the chamber 504 further configured to collect a first portion of the blood sample when under a drawing force applied from the outlet port 518 from the blood sample collection device 506 “The vacuum in each of the one or more sample vessels 506 causes blood to pass from the vein 520 to the diversion mechanism 512. The diversion mechanism 512 can be adjusted to divert the flow of blood to either the one or more pre-sample reservoirs 504 or to the second needle 510 inserted into one of the one or more sample vessels 506” (0040).
8. The device further comprising a 702, 704 valve that is configured to initially close off the sampling channel 710 until the first portion of the blood sample is in the chamber 504, when in the first position shown in Figure 7A because lumen 706 of the output flow-control block 704 is aligned with first lumen 708 (and not second lumen 710), which thus leads to the pre-sample reservoir/chamber 504 (0045), best seen in Figure 7A, and
is further configured such that, upon release, follow-on amounts of the blood sample will bypass the chamber 504 and flow through the sampling channel 710 toward the outlet port 518, best seen in Figure 7B – “when the input flow-control block 702 and the output flow-control block 704 are in a second position… the flow of blood input from the flexible, sterile input tubing 514 passes through the lumen 706 of the input flow-control block 702 and through the second lumen 710 of the output flow-control block 704 and into the one or more sample vessels (not shown) via the second sterile output tubing 518” (0046).
9. The device in accordance with claim 3, further comprising a patient needle 508, best seen in Figure 5 – “first needle 508 can be inserted into a patient to procure a blood sample” (0040) and the blood sample collection device 506, best seen in Figure 5.
10. The device, further comprising a moving part 702, 704 – input flow-control block and output flow-control block – “the input flow-control block 702 and the output flow-control block 704 can be slid back and forth between a first position (see FIG. 7A) and a second position (see FIG. 7B),
configured to be movable from a first position, best seen in Figure 7A, in which the inlet port 514 is in fluid communication with the chamber – “when the input flow-control block 702 and the output flow-control block 704 are in a first position… the flow of blood input from the flexible, sterile input tubing 514 passes through the lumen 706 of the input flow-control block 702 and through the first lumen 708 of the output flow-control block 704 and into the pre-sample reservoir (not shown) via the first sterile output tubing 516” (0045),
to a second position, best seen in Figure 7B, to create a pathway from the inlet port 514 to the outlet port 518 to allow the blood sample to flow to the sampling channel 710 – “when the input flow-control block 702 and the output flow-control block 704 are in a second position… the flow of blood input from the flexible, sterile input tubing 514 passes through the lumen 706 of the input flow-control block 702 and through the second lumen 710 of the output flow-control block 704 and into the one or more sample vessels (not shown) via the second sterile output tubing 518” (0046).
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.
Claim(s) 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Patton, and further in view of Hayakawa et al (US Pub No. 20140221873).
Patton disclose the invention above but do not expressly disclose a blood impermeable membrane is configured to facilitate the chamber collecting the first portion of the blood sample.
Hayakawa et al teach that it is well-known in the art to provide an analogous blood sampling device comprising a blood impermeable membrane (hydrophobic & bacteria-impermeable filter) – “the blood sample container with the configurations disclosed in Patent Literature 2, the liquid level of initial flow blood in the container body rises as the initial flow blood flows into the container body. When the amount of the initial flow blood in the container body reaches a minimum amount required, the initial flow blood gets in contact with the hydrophobic and bacteria- impermeable filter in almost all the surfaces of the filter and automatically stops flowing into the container body. Consequently, a predetermined amount of the initial flow blood including the required minimum amount can be stored in the container body” (0007).
In other words, Hayakawa et al teach the blood impermeable membrane (hydrophobic & bacteria-impermeable filter) facilitates the collection of the blood sample because it allows the container body to collect a minimum required amount until the blood contacts the blood impermeable membrane, which then automatically stops the blood flow. The filter of Hayakawa et al is thus considered blood impermeable because once it is contacted by the blood, the blood flow stops. The filter is considered a membrane as broadly as has been claimed. Hayakawa et al also teach housing 2, 8 is separate from the blood impermeable membrane 12, best seen in Figure 1, as an effective configuration for the blood sampling device to include the blood impermeable membrane.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Patton such that it includes a blood impermeable membrane as taught by Hayakawa et al to effectively facilitate collection of the blood sample at a minimum required amount by stopping the blood flow when the amount is reached and contacts the blood impermeable membrane as taught by Hayakawa et al to effectively automate the amount of blood sampling, wherein in combination, Patton and Hayakawa et al thus teach:
4: the blood impermeable membrane of Hayakawa et al is configured to facilitate the chamber 504 of Patton collecting the first portion of the blood sample – it allows the blood to be collected at a minimum amount required until it contacts the blood impermeable membrane, then automatically stops the blood flow (0007 Hayakawa et al).
5. the blood impermeable membrane causes the first portion of the blood sample to back up into the chamber 504 of Patton following application of the vacuum applied from the outlet port 518 (0040 of Patton) – it allows the blood to be collected at a minimum amount required until it contacts the blood impermeable membrane, then automatically stops the blood flow (0007 Hayakawa et al).
6. (Original) The device in accordance with claim 6, further comprising a housing defined by version mechanism 512 of Patton, best seen in Figure 5 and also 7B-B, separate from the blood impermeable membrane taught by Hayakawa et al. Hayakawa et al also teach housing 2, 8 is separate from the blood impermeable membrane 12 in Figure 1, as an effective configuration for the blood sampling device that includes said the blood impermeable membrane.
7. the device is configured such that, when the vacuum is applied at the outlet port 518 (0040 of Patton), the first portion of the blood sample is drawn into the chamber 504 of Patton to contact a material that is blood impermeable as taught by Hayakawa et al.
Claim(s) 11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Patton in view of Bullington et al (US Pub No. 20140163419 – cited by applicant) and alternatively with Xu et al (US Pub No. 20160161511).
In regard to Claim 11 and 17, Bullington et al disclose a device comprising:
an inlet port 514 – input tubing – for receiving a blood sample, best seen in Figure 5 and 7A-B (0038-0039, 0044-0046);
a patient needle 508 in fluid communication with the inlet port – “first needle 508 can be inserted into a patient to procure a blood sample” (0040) and the blood sample collection device 506, best seen in Figure 5;
an outlet port 518 configured to be fluidically coupled to a separate blood sample collection device 506 (sample vessel), best seen in Figure 5-6 – “the blood flows into the one or more sample vessels (not shown) via the second sterile output tubing 518” (0042, 0040, 0038);
a chamber 504 (pre-sample reservoir) connected with the inlet port, best seen in Figure 5 and 7A-B, and
configured to collect a first portion of the blood sample – “the diversion mechanism 512 can be initially adjusted to divert blood to the one or more pre-sample reservoirs 504 until the one or more pre-sample reservoirs 504 are filled, or a desired amount of blood has been withdrawn, at which point the diversion mechanism 512 can be adjusted to divert the flow of blood to the one or more sample vessels 506” (0040),
the chamber having a volume relative to the volume of a patient needle, best seen in Figure 5,
a sampling channel 433 connected with the inlet port and configured to convey a subsequent portion of the blood sample to the outlet port, best seen in Figure 15 (0095),
a sampling channel 710 connected with the inlet port and configured to convey a subsequent portion of the blood sample (0040) to the outlet port 518, best seen in Figure 7B –
“flow of blood input from the flexible, sterile input tubing 514 passes through the lumen 706 of the input flow-control block 702 and through the second lumen 710 of the output flow-control block 704 and into the one or more sample vessels (not shown) via the second sterile output tubing 518” (0046).
However, Patton does not expressly disclose the chamber having a volume up to 20 times the volume of a patient needle and the chamber has a volume of less than 1.5 cubic centimeters. It is noted that Patton states the chamber is designed to collect an initial amount of blood that may contain contaminants (0031).
Bullington et al teach that it is well-known in the art to provide an analogous device for reducing contaminants in sampling blood from a vein comprising an analogous chamber 480 with a volume of less than 1.5 cubic centimeters, e.g. 0.1 mL (0094), as an adequate volume to collect an initial amount of blood into the chamber that may contain contaminants – “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. In some embodiments, the bodily-fluid can contain undesirable microbes such as, for example, dermally-residing microbes and/or other external contaminants" (0092 of Bullington et al).
Bullington et al disclose chamber 480 configured to contain from about 0.1 ml to about 3.0 ml (0094), with 0.1 ml being up to 20 times the volume of a patient needle as typically found in the art.
Alternatively, Xu et al teach that it is well-known in the art that a sampling needle provides 10-50 microliter volume (0007). If the needle is said to have 50 microliters, then chamber 480 can have 0.1 ml (100 microliter), which is 20 times the volume of the patient needle.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to have the patient needle of Patton modified by Bullington et al to have a volume that allows the chamber having a volume up to 20 times the volume of the patient needle as taught by Bullington e al and with Xu et al as an effective and well-known size for the patient needle for sampling the blood as well as have the chamber with a volume of less than 1.5 cubic centimeters as taught by Bullington et al to provide an adequate volume to collect the initial amount of blood into the chamber of Patton that may contain contaminants.
13. Patton disclose the device, the chamber 504 further configured to collect a first portion of the blood sample when under a drawing force applied from the outlet port 518 from the blood sample collection device 506 “The vacuum in each of the one or more sample vessels 506 causes blood to pass from the vein 520 to the diversion mechanism 512. The diversion mechanism 512 can be adjusted to divert the flow of blood to either the one or more pre-sample reservoirs 504 or to the second needle 510 inserted into one of the one or more sample vessels 506” (0040).
14. Patton disclose the device further comprising a 702, 704 valve that is configured to initially close off the sampling channel 710 until the first portion of the blood sample is in the chamber 504, when in the first position shown in Figure 7A because lumen 706 of the output flow-control block 704 is aligned with first lumen 708 (and not second lumen 710), which thus leads to the pre-sample reservoir/chamber 504 (0045), best seen in Figure 7A, and
is further configured such that, upon release, follow-on amounts of the blood sample will bypass the chamber 504 and flow through the sampling channel 710 toward the outlet port 518, best seen in Figure 7B – “when the input flow-control block 702 and the output flow-control block 704 are in a second position… the flow of blood input from the flexible, sterile input tubing 514 passes through the lumen 706 of the input flow-control block 702 and through the second lumen 710 of the output flow-control block 704 and into the one or more sample vessels (not shown) via the second sterile output tubing 518” (0046).
15. Patton disclose the device in accordance with claim 13, further comprising a patient needle 508, best seen in Figure 5 – “first needle 508 can be inserted into a patient to procure a blood sample” (0040) and the blood sample collection device 506, best seen in Figure 5.
16. Patton disclose the device, further comprising a moving part 702, 704 – input flow-control block and output flow-control block – “the input flow-control block 702 and the output flow-control block 704 can be slid back and forth between a first position (see FIG. 7A) and a second position (see FIG. 7B),
configured to be movable from a first position, best seen in Figure 7A, in which the inlet port 514 is in fluid communication with the chamber – “when the input flow-control block 702 and the output flow-control block 704 are in a first position… the flow of blood input from the flexible, sterile input tubing 514 passes through the lumen 706 of the input flow-control block 702 and through the first lumen 708 of the output flow-control block 704 and into the pre-sample reservoir (not shown) via the first sterile output tubing 516” (0045),
to a second position, best seen in Figure 7B, to create a pathway from the inlet port 514 to the outlet port 518 to allow the blood sample to flow to the sampling channel 710 – “when the input flow-control block 702 and the output flow-control block 704 are in a second position… the flow of blood input from the flexible, sterile input tubing 514 passes through the lumen 706 of the input flow-control block 702 and through the second lumen 710 of the output flow-control block 704 and into the one or more sample vessels (not shown) via the second sterile output tubing 518” (0046).
18. Bullington et al disclose the device in accordance with claim 17, wherein the chamber 480 has a volume of less than 1.0 cubic centimeter – “the first reservoir 480 can be configured to contain from about 0.1 ml to about 3.0 ml” (0094).
19. Bullington et al disclose the device in accordance with claim 17, wherein the chamber 480 has a volume from 0.5 cubic centimeters to 1.0 cubic centimeters – “the first reservoir 480 can be configured to contain from about 0.1 ml to about 3.0 ml” (0094).
20. Patton disclose the device, the chamber 504 further configured to collect a first portion of the blood sample when under a drawing force applied from the outlet port 518 from the blood sample collection device 506 “The vacuum in each of the one or more sample vessels 506 causes blood to pass from the vein 520 to the diversion mechanism 512. The diversion mechanism 512 can be adjusted to divert the flow of blood to either the one or more pre-sample reservoirs 504 or to the second needle 510 inserted into one of the one or more sample vessels 506” (0040).
21. Patton disclose the device further comprising a 702, 704 valve that is configured to initially close off the sampling channel 710 until the first portion of the blood sample is in the chamber 504, when in the first position shown in Figure 7A because lumen 706 of the output flow-control block 704 is aligned with first lumen 708 (and not second lumen 710), which thus leads to the pre-sample reservoir/chamber 504 (0045), best seen in Figure 7A, and
is further configured such that, upon release, follow-on amounts of the blood sample will bypass the chamber 504 and flow through the sampling channel 710 toward the outlet port 518, best seen in Figure 7B – “when the input flow-control block 702 and the output flow-control block 704 are in a second position… the flow of blood input from the flexible, sterile input tubing 514 passes through the lumen 706 of the input flow-control block 702 and through the second lumen 710 of the output flow-control block 704 and into the one or more sample vessels (not shown) via the second sterile output tubing 518” (0046).
22. Patton disclose the device in accordance with claim 20, further comprising a patient needle 508, best seen in Figure 5 – “first needle 508 can be inserted into a patient to procure a blood sample” (0040) and the blood sample collection device 506, best seen in Figure 5.
23. Patton disclose the device, further comprising a moving part 702, 704 – input flow-control block and output flow-control block – “the input flow-control block 702 and the output flow-control block 704 can be slid back and forth between a first position (see FIG. 7A) and a second position (see FIG. 7B),
configured to be movable from a first position, best seen in Figure 7A, in which the inlet port 514 is in fluid communication with the chamber – “when the input flow-control block 702 and the output flow-control block 704 are in a first position… the flow of blood input from the flexible, sterile input tubing 514 passes through the lumen 706 of the input flow-control block 702 and through the first lumen 708 of the output flow-control block 704 and into the pre-sample reservoir (not shown) via the first sterile output tubing 516” (0045),
to a second position, best seen in Figure 7B, to create a pathway from the inlet port 514 to the outlet port 518 to allow the blood sample to flow to the sampling channel 710 – “when the input flow-control block 702 and the output flow-control block 704 are in a second position… the flow of blood input from the flexible, sterile input tubing 514 passes through the lumen 706 of the input flow-control block 702 and through the second lumen 710 of the output flow-control block 704 and into the one or more sample vessels (not shown) via the second sterile output tubing 518” (0046).
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.
It is noted that the items that have not been considered in the IDS filed 2/20/2026 are crossed out because no English translation has been provided.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached on (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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