DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
The applicant's amendments and arguments/remarks have been fully considered but are moot in view of the new grounds of rejections presented herein. Specifically, the examiner has provided the Galvao reference to teach the limitations presented in the newly amended claims.
Response to Amendment
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 22 and 43 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 22 recites ‘a first state’ and is dependent back to claim 21 which recites the same making it unclear if the recitation in claim 22 is meant to refer to that in claim 21 or not. For the purposes of examination they will be treated as the same element.
Claim 22 recites ‘a second state’ and is dependent back to claim 21 which recites the same making it unclear if the recitation in claim 22 is meant to refer to that in claim 21 or not. For the purposes of examination they will be treated as the same element.
Claim 43 recites ‘a first state’ and is dependent back to claim 36 which recites the same making it unclear if the recitation in claim 43 is meant to refer to that in claim 36 or not. For the purposes of examination they will be treated as the same element.
Claim 43 recites ‘a second state’ and is dependent back to claim 36 which recites the same making it unclear if the recitation in claim 43 is meant to refer to that in claim 36 or not. For the purposes of examination they will be treated as the same element.
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.
Claim(s) 21, 22, 25, 27, 36-37, 40, 42-43, and 51-52 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 Galvao (US 2004/0127816).
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 device including an inlet (Figure 1), an outlet (Figure 1), a first portion (Figure 1), a second portion (Figure 1), the method comprising:
establishing fluid communication between a vasculature of the patient and the inlet of the device (Paragraph 0054; Figure 1);
receiving a first volume of blood from the patient into the 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 the second portion of the device to the 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”).
Mathias is silent on a valve disposed in the device and in fluid communication with the first portion and the second portion, while the valve is in a first state, the valve in the first state allowing blood to flow into the first portion while blocking blood from flowing into the second portion, and the valve transitioning from the first state to a second state.
Galvao teaches a sample procurement device to obtain from a patient a blood sample for blood culture testing (Abstract), the device including an inlet, an outlet, a first portion, a second portion, and a valve disposed in the device and in fluid communication with the first portion and the second portion (Figures 1-5; the valve being element 72).
establishing fluid communication between a vasculature of the patient and the inlet of the device while the valve is in a first state, the valve in the first state allowing blood to flow into the first portion while blocking blood from flowing into the second portion (Paragraphs 0036-0041; valve is selectively slidable to allow blood flow into desired portions and block blood flow into undesired portions),
in response to the first volume of blood filling the first portion of the device and the valve transitioning from the first state to a second state, sequestering, in the first portion of the device, and receiving a second volume of blood (Paragraphs 0036-0041; valve is selectively slidable to allow blood flow into desired portions and block blood flow into undesired portions),
It would have been obvious to one of ordinary skill in the art to have modified Mathias with Galvao because it allows better vacuum control to allow proper drawing of a patient’s blood (Paragraph 0036 of Galvao).
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 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 device including an inlet (Figure 1), an outlet (Figure 1), a first portion (Figure 1), a second portion (Figure 1), the method comprising:
establishing fluid communication between a vasculature of the patient and an inlet of 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 the second portion of the device and toward the 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”).
Mathias is silent on a valve disposed in the device and in fluid communication with the first portion and the second portion, while the valve is in a first state, the valve in the first state allowing blood to flow into the first portion while blocking blood from flowing into the second portion, and the valve transitioning from the first state to a second state.
Galvao teaches a sample procurement device to obtain from a patient a blood sample for blood culture testing (Abstract), the device including an inlet, an outlet, a first portion, a second portion, and a valve disposed in the device and in fluid communication with the first portion and the second portion (Figures 1-5; the valve being element 72).
receiving a first volume of blood from the patient into a first portion of the device while the valve is in a first state, the valve in the first state allowing blood to flow into the first portion while blocking blood from flowing into the second portion (Paragraphs 0036-0041; valve is selectively slidable to allow blood flow into desired portions and block blood flow into undesired portions),
when blood stops flowing to the first portion of the device and after the valve transitions from the first state to a second state, receiving a second volume of blood from the patient (Paragraphs 0036-0041; valve is selectively slidable to allow blood flow into desired portions and block blood flow into undesired portions.
It would have been obvious to one of ordinary skill in the art to have modified Mathias with Galvao because it allows better vacuum control to allow proper drawing of a patient’s blood (Paragraph 0036 of Galvao).
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 the 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).
Galvao more explicitly teaches the valve as shown in the rejection for claim 36 above thus in combination Mathias in view of Galvao teaches sequestering the first volume of blood and contaminants contained therein in the first portion of the device using the valve of the device.
It would have been obvious to one of ordinary skill in the art to have modified Mathias with Galvao because it allows better vacuum control to allow proper drawing of a patient’s blood (Paragraph 0036 of Galvao).
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 51, Mathias is silent on the valve. Galvao teaches wherein the first portion includes a first lumen, and the second portion includes a second lumen, the valve is disposed at a junction between the first lumen and the second lumen (Paragraphs 0036-0041; valve is selectively slidable to allow blood flow into desired portions and block blood flow into undesired portions). It would have been obvious to one of ordinary skill in the art to have modified Mathias with Galvao because it allows better vacuum control to allow proper drawing of a patient’s blood (Paragraph 0036 of Galvao).
Regarding claim 52, Mathias is silent on the valve. Galvao teaches wherein the first portion includes a first lumen, and the second portion includes a second lumen, the valve is disposed at a junction between the first lumen and the second lumen (Paragraphs 0036-0041; valve is selectively slidable to allow blood flow into desired portions and block blood flow into undesired portions). It would have been obvious to one of ordinary skill in the art to have modified Mathias with Galvao because it allows better vacuum control to allow proper drawing of a patient’s blood (Paragraph 0036 of Galvao).
Claims 23-24 and 38-39 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 Galvao (US 2004/0127816) and in further 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 1 ml 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 1ml 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 Galvao (US 2004/0127816) and in further 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Golden (US Patent No. 4676256).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JASON SIMS can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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