DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Examiner’s Note
Examiner notes the filing of a terminal disclaimer over the parent application to put the application in condition for allowance was discussed with Attorney of Record Georgia Robbins on November 19, 2025. A terminal disclaimer was filed and approved on November 21, 2025. On November 26, 2025 an IDS was filed in the application. The following prior art rejection is made in light of prior art found from reviewing that IDS filed November 26, 2025.
Claim Objections
Applicant is advised that should claim 21 be found allowable, claim 28 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). And vice versa.
Applicant is advised that should claim 36 be found allowable, claim 44 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). And vice versa.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-‘sample procurement device’ in claims 21, 28, 36, and 44 interpreted to be needles and lumens per Paragraphs 0023-0024 of the published specification and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24, 32, 39, and 49 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites ‘the first volume of blood is greater than a volume of the lumen of the needle and less than 5mL’. Per the published specification (Paragraph 0035) it would appear the first volume of blood can be between 2mL and 10mL which therefore can imply that the first volume of blood is 6mL, 7mL, 8mL, 9mL, and 10mL but is also at the same time somehow less than 5mL thus making the scope of the claim unclear. For examination purposes it will be treated as ‘the first volume of blood is greater than 0 mL and less than 5mL’. This similarly applies to claims 32, 39, and 49.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 21, 22, 25, 27-30, 33-37, 40, 42-47, and 50 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Mathias et al. (US 2005/0148993).
Regarding claim 21, Mathias teaches a method of using a sample procurement device to obtain from a patient a blood sample for blood culture testing (Abstract), the method comprising:
establishing fluid communication between a vasculature of the patient and the device (Paragraph 0054; Figure 1);
receiving a first volume of blood from the patient into a first portion of the device (Paragraph 0054; first volume into 42 as part of 18);
in response to the first volume of blood filling the first portion of the device (Paragraph 0055; once sufficient volume has been collected):
sequestering, in the first portion of the device, contaminants contained in the first volume of blood (Paragraph 0077; “An advantage of pre-donation sampling is that bacteria or foreign substances that may be present on the donor's skin will not be transmitted to collection container 16, but will be diverted to sampling container 42”); and
receiving a second volume of blood from the patient such that the second volume of blood bypasses the first portion of the device and the contaminants sequestered therein and flows through a second portion of the device to an outlet of the device (Paragraph 0055; line 62 closed and clamp 66 is opened to allow flow through 15 into container 16; Further see Paragraphs 0075-0077; “An advantage of pre-donation sampling is that bacteria or foreign substances that may be present on the donor's skin will not be transmitted to collection container 16, but will be diverted to sampling container 42”),
wherein the second volume of blood bypassing the first portion of the device reduces contamination that can lead to false results in blood culture tests of the second volume of blood (Paragraph 0077; “An advantage of pre-donation sampling is that bacteria or foreign substances that may be present on the donor's skin will not be transmitted to collection container 16, but will be diverted to sampling container 42”).
Regarding claim 22, Mathias teaches wherein the device transitions from a first state to a second state as a result of filling the first portion of the device (Paragraph 0055; transition being which clamps are opened/closed).
Regarding claim 25, Mathias teaches further comprising: establishing fluid communication between the outlet and a sample vessel containing a culture medium (Figure 1; through 15 into 16; Paragraph 0044); and providing through the outlet the second volume of blood into the sample vessel (Paragraph 0055; line 62 closed and clamp 66 is opened to allow flow through 15 into container 16).
Regarding claim 27, Mathias teaches wherein the first portion of the device defines a first fluid flow path in fluid communication with an inlet of the device and the second portion of the device defines a second fluid flow path in fluid communication with the inlet and the outlet (Figure 1; different tubing creates different flow paths).
Regarding claim 28, Mathias teaches a method of using a sample procurement device to obtain from a patient a blood sample for blood culture testing (Abstract), the method comprising:
establishing fluid communication between a vasculature of the patient and the device (Paragraph 0054; Figure 1);
receiving a first volume of blood from the patient into a first portion of the device (Paragraph 0054; first volume into 42 as part of 18);
sequestering, in the first portion of the device, contaminants contained in the first volume of blood (Paragraph 0077; “An advantage of pre-donation sampling is that bacteria or foreign substances that may be present on the donor's skin will not be transmitted to collection container 16, but will be diverted to sampling container 42”); and
after receiving the first volume of blood in the first portion of the device (Paragraph 0055; once sufficient volume has been collected), receiving a second volume of blood from the patient such that the second volume of blood flows through the second portion of the device toward an outlet of the device (Paragraph 0055; line 62 closed and clamp 66 is opened to allow flow through 15 into container 16) while bypassing the first portion of the device and the contaminants sequestered therein (Paragraphs 0075-0077; “An advantage of pre-donation sampling is that bacteria or foreign substances that may be present on the donor's skin will not be transmitted to collection container 16, but will be diverted to sampling container 42”).
wherein the second volume of blood bypassing the first portion of the device reduces contamination that can lead to false results in blood culture tests of the second volume of blood (Paragraph 0077; “An advantage of pre-donation sampling is that bacteria or foreign substances that may be present on the donor's skin will not be transmitted to collection container 16, but will be diverted to sampling container 42”).
Regarding claim 29, Mathias teaches wherein the first portion of the device is a pre-sample reservoir (Paragraph 0077; “An advantage of pre-donation sampling is that bacteria or foreign substances that may be present on the donor's skin will not be transmitted to collection container 16, but will be diverted to sampling container 42”; pre-donation sampling container is considered a pre-sample reservoir).
Regarding claim 30, Mathias teaches wherein the device is in a first state during the receiving the first volume of blood from the patient into the first portion of the device, the method further comprising: transitioning the device from the first state to a second state when blood stops flowing to the first portion of the device (Paragraph 0055; transition being which clamps are opened/closed).
Regarding claim 33, Mathias teaches further comprising: establishing fluid communication between the outlet and a sample vessel containing a culture medium (Figure 1; through 15 into 16; Paragraph 0044); and providing through the outlet the second volume of blood into the sample vessel (Paragraph 0055; line 62 closed and clamp 66 is opened to allow flow through 15 into container 16).
Regarding claim 34, Mathias wherein the contaminants contained in the first volume of blood are automatically sequestered using a valve of the device (Paragraph 0075; The disposable processing set and sampling system of the present invention provide many benefits. One benefit is that a blood sample may be obtained prior to the donation while still preserving the sterility of flow path between the donor and collection container. Specifically, as described above, a blood sample may be collected in container 42 (or 142), which container may then be isolated from the remainder of the system (by, for example, sealing or clipping)’; sealing or clipping acts as a valve since they control flow of fluid).
Regarding claim 35, Mathias teaches wherein the first portion of the device defines a first fluid flow path in fluid communication with an inlet of the device and the second portion of the device defines a second fluid flow path in fluid communication with the inlet and the outlet (Figure 1; different tubing creates different flow paths))
Regarding claim 36, Mathias teaches a method of using a sample procurement device to obtain from a patient a blood sample for blood culture testing (Abstract), the method comprising:
establishing fluid communication between a vasculature of the patient and the device (Paragraph 0054; Figure 1);
receiving a first volume of blood from the patient into a first portion of the device (Paragraph 0054; first volume into 42 as part of 18); and
when blood stops flowing to the first portion of the device (Paragraph 0055; once sufficient volume has been collected), receiving a second volume of blood from the patient such that the second volume of blood flows through a second portion of the device and toward an outlet of the device (Paragraph 0055; line 62 closed and clamp 66 is opened to allow flow through 15 into container 16), while bypassing the first portion of the device and contaminants contained in the first volume of blood (Paragraphs 0075-0077; “An advantage of pre-donation sampling is that bacteria or foreign substances that may be present on the donor's skin will not be transmitted to collection container 16, but will be diverted to sampling container 42”),
wherein the second volume of blood bypassing the first portion of the device reduces contamination that can lead to false results in blood culture tests of the second volume of blood (Paragraph 0077; “An advantage of pre-donation sampling is that bacteria or foreign substances that may be present on the donor's skin will not be transmitted to collection container 16, but will be diverted to sampling container 42”).
Regarding claim 37, Mathias teaches wherein the first portion of the device is a pre-sample reservoir (Paragraph 0077; “An advantage of pre-donation sampling is that bacteria or foreign substances that may be present on the donor's skin will not be transmitted to collection container 16, but will be diverted to sampling container 42”; pre-donation sampling container is considered a pre-sample reservoir).
Regarding claim 40, Mathias teaches further comprising: establishing fluid communication between the outlet and a sample vessel containing a culture medium (Figure 1; through 15 into 16; Paragraph 0044); and providing through the outlet the second volume of blood into the sample vessel (Paragraph 0055; line 62 closed and clamp 66 is opened to allow flow through 15 into container 16).
Regarding claim 42, Mathias teaches further comprising: sequestering the first volume of blood and contaminants contained therein in the first portion of the device using a valve of the device (Paragraph 0075; The disposable processing set and sampling system of the present invention provide many benefits. One benefit is that a blood sample may be obtained prior to the donation while still preserving the sterility of flow path between the donor and collection container. Specifically, as described above, a blood sample may be collected in container 42 (or 142), which container may then be isolated from the remainder of the system (by, for example, sealing or clipping)’; sealing or clipping acts as a valve since they control flow of fluid).
Regarding claim 43, Mathias teaches wherein the device is in a first state during the receiving the first volume of blood from the patient into the first portion of the device, the method further comprising: transitioning the device from the first state to a second state when blood stops flowing to the first portion of the device (Paragraph 0055; transition being which clamps are opened/closed).
Regarding claim 44, Mathias teaches a method of using a sample procurement device to obtain from a patient a blood sample for blood culture testing (Abstract), the method comprising:
establishing fluid communication between a vasculature of the patient and the device (Paragraph 0054; Figure 1);
receiving a flow of blood from the patient into a first portion of the device (Paragraph 0054; first volume into 42 as part of 18);
after a first volume of the blood fills the first portion of the device (Paragraph 0055; once sufficient volume has been collected), receiving a flow of blood from the patient into a second portion of the device (Paragraph 0055; line 62 closed and clamp 66 is opened to allow flow through 15 into container 16); and
conveying a second volume of blood through the second portion of the device to an outlet of the device while bypassing the first portion of the device and contaminants contained in the first volume of blood (Paragraphs 0075-0077; “An advantage of pre-donation sampling is that bacteria or foreign substances that may be present on the donor's skin will not be transmitted to collection container 16, but will be diverted to sampling container 42”).,
wherein the second volume of blood bypassing the first portion of the device reduces contamination that can lead to false results in blood culture tests of the second volume of blood (Paragraph 0077; “An advantage of pre-donation sampling is that bacteria or foreign substances that may be present on the donor's skin will not be transmitted to collection container 16, but will be diverted to sampling container 42”).
Regarding claim 45, Mathias teaches further comprising: establishing fluid communication between the outlet and a sample vessel containing a culture medium (Figure 1; through 15 into 16; Paragraph 0044); and providing through the outlet the second volume of blood into the sample vessel (Paragraph 0055; line 62 closed and clamp 66 is opened to allow flow through 15 into container 16).
Regarding claim 46, Mathias teaches wherein the first portion of the device is a pre-sample reservoir (Paragraph 0077; “An advantage of pre-donation sampling is that bacteria or foreign substances that may be present on the donor's skin will not be transmitted to collection container 16, but will be diverted to sampling container 42”; pre-donation sampling container is considered a pre-sample reservoir).
Regarding claim 47, Mathias teaches wherein the device is in a first state during the receiving the flow of blood from the patient into the first portion of the device, the method further comprising: transitioning the device from the first state to a second state when blood stops flowing to the first portion of the device (Paragraph 0055; transition being which clamps are opened/closed).
Regarding claim 50, Mathias teaches wherein the first portion of the device defines a first fluid flow path in fluid communication with an inlet of the device and the second portion of the device defines a second fluid flow path in fluid communication with the inlet and the outlet (Figure 1; different tubing creates different flow paths).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 23-24, 31-32, 38-39, and 48-49 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mathias et al. (US 2005/0148993) in view of Romanschin et al. (US Patent No. 6306614).
Regarding claim 23, Mathias is silent on the amount the first volume of blood is.Romaschin teaches wherein the first volume of blood is less than 5 ml (Column 12, Lines 29-32).
Romaschin teaches it is known to use 3 ml vacuum tubes for blood sampling from a venipuncture or arterial line (Column 12, Lines 29-32; conventional equipment). Therefore it would have been obvious to one of ordinary skill in the art to use a 3 ml sample tube as the first reservoir in the Mathias method as taught by Romaschin as it is well known to use vacuum tubes of less than 5 ml for blood sampling and would yield predictable results.
Regarding claim 24, Mathias teaches wherein establishing fluid communication with the vasculature of the patient and the device includes inserting a needle having a lumen into the vasculature of the patient (Paragraph 0054), but is silent on the amount the first volume of blood is. Romaschin teaches the first volume of blood is greater than a volume of the lumen of the needle and less than 5 ml (Column 12, Lines 29-32).
Romaschin teaches it is known to use 3 ml vacuum tubes for blood sampling from a venipuncture or arterial line (Column 12, Lines 29-32; conventional equipment). Therefore it would have been obvious to one of ordinary skill in the art to use a 3 ml sample tube as the first reservoir in the Mathias method as taught by Romaschin as it is well known to use vacuum tubes of less than 5 ml for blood sampling and would yield predictable results.
Regarding claim 31, Mathias is silent on the amount the first volume of blood is.Romaschin teaches wherein the first volume of blood is less than 5 ml (Column 12, Lines 29-32).
Romaschin teaches it is known to use 3 ml vacuum tubes for blood sampling from a venipuncture or arterial line (Column 12, Lines 29-32; conventional equipment). Therefore it would have been obvious to one of ordinary skill in the art to use a 3 ml sample tube as the first reservoir in the Mathias method as taught by Romaschin as it is well known to use vacuum tubes of less than 5 ml for blood sampling and would yield predictable results.
Regarding claim 32, Mathias teaches wherein establishing fluid communication with the vasculature of the patient and the device includes inserting a needle having a lumen into the vasculature of the patient (Paragraph 0054), but is silent on the amount the first volume of blood is. Romaschin teaches the first volume of blood is greater than a volume of the lumen of the needle and less than 5 ml (Column 12, Lines 29-32).
Romaschin teaches it is known to use 3 ml vacuum tubes for blood sampling from a venipuncture or arterial line (Column 12, Lines 29-32; conventional equipment). Therefore it would have been obvious to one of ordinary skill in the art to use a 3 ml sample tube as the first reservoir in the Mathias method as taught by Romaschin as it is well known to use vacuum tubes of less than 5 ml for blood sampling and would yield predictable results.
Regarding claim 38, Mathias is silent on the amount the first volume of blood is.Romaschin teaches wherein the first volume of blood is less than 5 ml (Column 12, Lines 29-32).
Romaschin teaches it is known to use 3 ml vacuum tubes for blood sampling from a venipuncture or arterial line (Column 12, Lines 29-32; conventional equipment). Therefore it would have been obvious to one of ordinary skill in the art to use a 3 ml sample tube as the first reservoir in the Mathias method as taught by Romaschin as it is well known to use vacuum tubes of less than 5 ml for blood sampling and would yield predictable results.
Regarding claim 39, Mathias teaches wherein establishing fluid communication with the vasculature of the patient and the device includes inserting a needle having a lumen into the vasculature of the patient (Paragraph 0054), but is silent on the amount the first volume of blood is. Romaschin teaches the first volume of blood is greater than a volume of the lumen of the needle and less than 5 ml (Column 12, Lines 29-32).
Romaschin teaches it is known to use 3 ml vacuum tubes for blood sampling from a venipuncture or arterial line (Column 12, Lines 29-32; conventional equipment). Therefore it would have been obvious to one of ordinary skill in the art to use a 3 ml sample tube as the first reservoir in the Mathias method as taught by Romaschin as it is well known to use vacuum tubes of less than 5 ml for blood sampling and would yield predictable results.
Regarding claim 48, Mathias is silent on the amount the first volume of blood is. Romaschin teaches wherein the first volume of blood is less than 5 ml (Column 12, Lines 29-32).
Romaschin teaches it is known to use 3 ml vacuum tubes for blood sampling from a venipuncture or arterial line (Column 12, Lines 29-32; conventional equipment). Therefore it would have been obvious to one of ordinary skill in the art to use a 3 ml sample tube as the first reservoir in the Mathias method as taught by Romaschin as it is well known to use vacuum tubes of less than 5 ml for blood sampling and would yield predictable results.
Regarding claim 49, Mathias teaches wherein establishing fluid communication with the vasculature of the patient and the device includes inserting a needle having a lumen into the vasculature of the patient (Paragraph 0054), but is silent on the amount the first volume of blood is. Romaschin teaches the first volume of blood is greater than a volume of the lumen of the needle and less than 5 ml (Column 12, Lines 29-32).
Romaschin teaches it is known to use 3 ml vacuum tubes for blood sampling from a venipuncture or arterial line (Column 12, Lines 29-32; conventional equipment). Therefore it would have been obvious to one of ordinary skill in the art to use a 3 ml sample tube as the first reservoir in the Mathias method as taught by Romaschin as it is well known to use vacuum tubes of less than 5 ml for blood sampling and would yield predictable results.
Claims 26 and 41 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mathias et al. (US 2005/0148993) in view of Olson et al. (US Patent No. 5122129).
Regarding claim 26, Mathias is silent on the vacuum in the sample vessel. Olson teaches wherein in response to fluid communication being established between the outlet and the sample vessel, the method further comprising: creating, as a result of a vacuum contained within the sample vessel, a pressure difference between an inlet of the device and the outlet to draw the second volume of blood through the second portion of the device to the outlet and into the sample vessel (Column 6, Lines 38-Column 7, Line 21; use of an evacuated sample container would provide this functionality). It would have been obvious to one of ordinary skill in the art to have modified Mathias with Olson because evacuated tube usage for sampling is known and conventional in the art as acknowledged by Olson (Column 3, Lines 32-34 of Olson) thus one of ordinary skill in the art would understand using one would yield predictable results.
Regarding claim 41, Mathias is silent on the vacuum in the sample vessel. Olson teaches wherein in response to fluid communication being established between the outlet and the sample vessel, the method further comprising: creating, as a result of a vacuum contained with the sample vessel, a pressure difference between an inlet of the device and the outlet to draw the second volume of blood through the second portion of the device to the outlet and into the sample vessel (Column 6, Lines 38-Column 7, Line 21; use of an evacuated sample container would provide this functionality). It would have been obvious to one of ordinary skill in the art to have modified Mathias with Olson because evacuated tube usage for sampling is known and conventional in the art as acknowledged by Olson (Column 3, Lines 32-34 of Olson) thus one of ordinary skill in the art would understand using one would yield predictable results.
Conclusion
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791