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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
1. Claims 12-15, 18-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ugwuanyi et al. in view of Carroll et al.
Ugwuanyi et al. teaches a procedure on page 47 in which two test tubes labeled ‘TEST’ and ‘BLANK’ were set up. About 500µl serum sample was pipetted into the TEST test tube. Then 1.5ml distilled water was added to the TEST tube and 2.0ml distilled water to the BLANK test tube. This was followed by 0.5ml of 2/3NH2SO4 and 0.5ml of 10% sodium tungstate added to each of the test tubes.
Ugwuanyi et al. does not teach that the sodium tungstate was immobilized in the test tube.
Carroll et al. teaches coating test tubes with reagents that are used to process blood samples (column 4, lines 57-59). The coatings of Carroll et al. are sprayed on and dried (See Abstract).
It would have been obvious to one of ordinary skill in the art to modify Ugwuanyi et al. and apply the sodium tungstate as a spray-dried coating on the test tubes for purposes of pre-loading the test tubes with sodium tungstate for convenience.
The limitations in applicant’s claim 12 that the device is “configured for collection of and subsequent testing phosphatidylethanol (PEth) in a blood sample of less than 10 ml, do not incorporate any structural limitations to the device or distinguish over the test tubes of Ugwuanyi et al. or Carroll et al. Further sodium tungstate is an inhibitor of the enzyme phospholipase D (PLD).
I.) Regarding applicant’s claim 12, as noted above, Ugwuanyi et al. in view of Carroll et al. teaches all the structural elements of claim 12.
Therefore, Ugwuanyi et al. in view of Carroll et al. renders claim 12 obvious.
II.) Regarding applicant’s claim 13, as noted above Ugwuanyi et al. in view of Carroll et al. renders claim 12 obvious from which claim 13 depends.
Claim 13 recites that the PLD inhibitor is selected from at least one of a salt comprising a vanadium oxyanion and a salt comprising a tungsten oxyanion.
As noted above, Ugwuanyi et al. teaches sodium tungstate.
Therefore, Ugwuanyi et al. in view of Carroll et al. renders claim 13 obvious.
III.) Regarding applicant’s claim 14, as noted above Ugwuanyi et al. in view of Carroll et al. renders claim 13 obvious from which claim 14 depends.
Claim 14 recites that the PLD inhibitor is selected from at least one of NaVO3 (sodium metavanadate) and Na2WO4 (sodium tungstate).
As noted above, Ugwuanyi et al. teaches sodium tungstate.
Therefore, Ugwuanyi et al. in view of Carroll et al. renders claim 14 obvious.
IV.) Regarding applicant’s claim 15, as noted above Ugwuanyi et al. in view of Carroll et al. renders claim 12 obvious from which claim 15 depends.
Claim 15 recites that the at least one salt has a mass of less than 10 mg.
Ugwuanyi et al. teaches 0.5ml of 10% sodium tungstate in the test tubes.
Therefore, Ugwuanyi et al. in view of Carroll et al. renders claim 15 obvious.
V.) Regarding applicant’s claim 18, as noted above Ugwuanyi et al. in view of Carroll et al. renders claim 17 obvious which claim 18 depends.
Claim 18 recites that the test tube comprises a bottom, a lid and a coating.
The test tubes of Ugwuanyi et al. necessarily have bottoms, but are not disclosed as having a lid and a coating.
As noted above, Ugwuanyi et al. teaches adding sodium tungstate to the test tubes.
Carroll et al. teaches test tubes with lids and teaches coating test tubes with reagents that are used to process blood samples (column 4, lines 57-59). The coatings of Carroll et al. are sprayed on and dried (See Abstract).
It would have been obvious to one of ordinary skill in the art to modify Ugwuanyi et al. and apply the sodium tungstate as a spray-dried coating on the test tubes for purposes of pre-loading the test tubes with sodium tungstate for convenience. It would further have been obvious to include a lid on the test tubes of Ugwuanyi et al. to prevent spilling of the contents.
Therefore, Ugwuanyi et al. in view of Carroll et al. renders claim 18 obvious.
VI.) Regarding applicant’s claim 19, as noted above Ugwuanyi et al. in view of Carroll et al. renders claim 18 obvious from which claim 18 depends.
Claim 19 recites that test tube has an inner coating of less than 100 micrometers comprising the at least one inhibitor of the enzyme phospholipase D.
Ugwuanyi et al. in view of Carroll et al. does not teach that test tube has an inner coating of less than 100 micrometers comprising the at least one inhibitor of the enzyme phospholipase D.
One skilled in the art could conduct routine optimization experimentation to determined suitable thickness of the sodium tungstate and provide a thickness of less than 100 micrometers.
Therefore Ugwuanyi et al. in view of Carroll et al. renders claim 19 obvious.
VII.) Regarding applicant’s claim 20, as noted above Ugwuanyi et al. in view of Carroll et al. renders claim 19 obvious from which claim 20 depends.
Claim 20 recites that the inner coating is sprayed on the bottom and/or on the lid of the test tube.
As noted above, Carroll et al. teaches spraying coating onto the inner surfaces (including bottoms, per Fig. 1) of test tubes.
Therefore, Ugwuanyi et al. in view of Carroll et al. renders claim 20 obvious.
VIII.) Regarding applicant’s claim 22, claim 22 recites a method of applying a coating of at least one inhibitor of the enzyme phospholipase D (PLD) selected from at least one of a salt of vanadium and a salt of tungsten to a test tube, comprising the steps of: stabilizing the test tube in a substantially vertical position; inserting a spray nozzle inside the test tube, the spray nozzle being in fluid communication with a container holding a solution comprising the at least one PLD inhibitor; spraying the solution comprising the at least one PLD inhibitor inside the test tube; and allowing the solution comprising the at least PLD one inhibitor to dry.
As noted above Ugwuanyi et al. teaches a procedure in which sodium tungstate is provide in test tubes.
As noted above, Ugwuanyi et al. teaches adding sodium tungstate to the test tubes.
Ugwuanyi et al. does not teaching coating the test tubes with sodium tungstate.
Carroll et al. teaches test tubes with lids and coating test tubes with reagents that are used to process blood samples (column 4, lines 57-59). The coatings of Carroll et al. are sprayed on and dried (See Abstract).
It would have been obvious to one of ordinary skill in the art to modify Ugwuanyi et al. and apply the sodium tungstate as a spray-dried coating on the test tubes for purposes of pre-loading the test tubes with sodium tungstate for convenience.
Therefore, Ugwuanyi et al. in view of Carroll et al. renders claim 22 obvious.
2. Claims 12-17, 18-20 and 22 are rejected under 35 U.S.C. 103 as being obvious over Campbell et al. in view of Carroll et al.
On page 174 Campbell et al. teaches a procedure in which a blood sample it pipetted into a tube into which sodium tungstate is added.
Campbell et al. does not teach that the sodium tungstate was immobilized in the test tube.
Carroll et al. teaches coating test tubes with reagents that are used to process blood samples (column 4, lines 57-59). The coatings of Carroll et al. are sprayed on and dried (See Abstract).
It would have been obvious to one of ordinary skill in the art to modify Campbell et al. and apply the sodium tungstate as a spray-dried coating on the test tubes for purposes of pre-loading the test tubes with sodium tungstate for convenience.
The limitations in applicant’s claim 12 that the device is “configured for collection of and subsequent testing phosphatidylethanol (PEth) in a blood sample of less than 10 ml, do not incorporate any structural limitations to the device or distinguish over the test tubes of Ugwuanyi et al. or Carroll et al. Further sodium tungstate is an inhibitor of the enzyme phospholipase D (PLD).
I.) Regarding applicant’s claim 12, as noted above, Campbell et al. in view of Carroll et al. teaches all the structural elements of claim 12.
Therefore, Campbell et al. in view of Carroll et al. renders claim 12 obvious.
II.) Regarding applicant’s claim 13, as noted above Campbell et al. in view of Carroll renders claim 12 obvious from which claim 13 depends.
Claim 13 recites that the PLD inhibitor is selected from at least one of a salt comprising a vanadium oxyanion and a salt comprising a tungsten oxyanion.
As noted above, Campbell et al. teaches sodium tungstate.
Therefore, Campbell et al. in view of Carroll et al. renders claim 13 obvious.
III.) Regarding applicant’s claim 14, as noted above Campbell et al. in view of Carroll et al. renders claim 13 obvious from which claim 14 depends.
Claim 14 recites that the PLD inhibitor is selected from at least one of NaVO3 (sodium metavanadate) and Na2WO4 (sodium tungstate).
As noted above, Campbell et al. teaches sodium tungstate.
Therefore, Campbell et al. in view of Carroll et al. renders claim 14 obvious.
IV.) Regarding applicant’s claim 15, as noted above Campbell et al. in view of Carroll et al. renders claim 12 obvious from which claim 15 depends.
Claim 15 recites that the at least one salt has a mass of less than 10 mg.
Campbell et al. teaches 0.02 ml sodium tungstate.
Therefore, Campbell et al. in view of Carroll et al. renders claim 15
V.) Regarding applicant’s claim 16, as noted above Campbell et al. in view of Carroll et al. renders claim 12 obvious from which claim 16 depends.
Claim 16 recites that the at least one salt is present in amount that admits concentration of less than 1 mM in the blood sample.
Campbell et al. teaches 0.02 ml tungstate.
Therefore, Campbell et al. in view of Carroll et al. renders claim 16 obvious.
VI.) Regarding applicant’s claim 18, as noted above Campbell et al. in view of Carroll et al. renders claim 17 obvious from which claim 18 depends.
Claim 18 recites that the test tube comprises a bottom, a lid and a coating.
The test tubes of Campbell et al. necessarily have bottoms, but are not disclosed as having a lid and a coating.
As noted above, Campbell et al. teaches adding sodium tungstate to the test tubes.
Carroll et al. teaches test tubes with lids and coating test tubes with reagents that are used to process blood samples (column 4, lines 57-59). The coatings of Carroll et al. are sprayed on and dried (See Abstract).
It would have been obvious to one of ordinary skill in the art to modify Campbell et al. and apply the sodium tungstate as a spray-dried coating on the test tubes for purposes of pre-loading the test tubes with sodium tungstate for convenience. It would further have been obvious to include a lid on the test tubes of Campbell et al. to prevent spilling of the contents.
Therefore, Campbell et al. in view of Carroll et al. renders claim 18 obvious.
VII.) Regarding applicant’s claim 19, as noted above Campbell et al. in view of Carroll et al. renders claim 18 obvious from which claim 18 depends.
Claim 19 recites that test tube has an inner coating of less than 100 micrometers comprising the at least one inhibitor of the enzyme phospholipase D.
Campbell et al. in view of Carroll et al. does not teach that test tube has an inner coating of less than 100 micrometers comprising the at least one inhibitor of the enzyme phospholipase D.
Campbell et al. teaches 0.2 ml sodium tungstate.
When pre-coating the test tube with sodium tungstate and drying the sodium tungstate, one skilled in the art would conduct routine optimization experimentation to determine a suitable thickness of the sodium tungstate that provides a desired amount of the sodium tungstate for testing and provide a thickness of less than 100 micrometers of the sodium tungstate.
Therefore Campbell et al. in view of Carroll et al. renders claim 19 obvious.
VIII.) Regarding applicant’s claim 20, as noted above Campbell et al. in view of Carroll et al. renders claim 19 obvious from which claim 20 depends.
Claim 20 recites that the inner coating is sprayed on the bottom and/or on the lid of the test tube.
As noted above, Carroll et al. teaches spraying coating onto the inner surfaces (including bottoms, per Fig. 1) of test tubes.
Therefore, Campbell et al. in view of Carroll et al. renders claim 20 obvious.
IX.) Regarding applicant’s claim 22, claim 22 recites a method of applying a coating of at least one inhibitor of the enzyme phospholipase D (PLD) selected from at least one of a salt of vanadium and a salt of tungsten to a test tube, comprising the steps of: stabilizing the test tube in a substantially vertical position; inserting a spray nozzle inside the test tube, the spray nozzle being in fluid communication with a container holding a solution comprising the at least one PLD inhibitor; spraying the solution comprising the at least one PLD inhibitor inside the test tube; and allowing the solution comprising the at least PLD one inhibitor to dry.
As noted above Campbell et al. teaches a procedure in which sodium tungstate is provide in test tubes.
As noted above, Campbell et al. teaches adding sodium tungstate to the test tubes.
Campbell et al. does not teaching coating the test tubes with sodium tungstate.
Carroll et al. teaches test tubes with lids and coating test tubes with reagents that are used to process blood samples (column 4, lines 57-59). The coatings of Carroll et al. are sprayed on and dried (See Abstract).
It would have been obvious to one of ordinary skill in the art to modify Campbell et al. and apply the sodium tungstate as a spray-dried coating on the test tubes for purposes of pre-loading the test tubes with sodium tungstate for convenience.
Therefore, Campbell et al. in view of Carroll et al. renders claim 22 obvious.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive.
Applicant argues that Carroll discloses a device for plasma preparation comprising a spray-dried anticoagulant formulation on the interior surface of the device and a thixotropic polymeric gel and that amended claim 12 differs from the teachings of Carroll in that the test tube is configured for collection of blood sample and subsequent testing for phosphatidylethanol (PEth) and comprises an inhibitor of the enzyme phospholipase D immobilized in the test tube.
Carroll et al. has been relied upon as teaching that reagents can be applied as coatings onto test tubes, which is applicable to reagents used in test tubes for the processes of Ugwuanyi et al. and Campbell et al.
Applicant’s argument that the device claimed is “configured” for collection of blood sample and subsequent testing for phosphatidylethanol (PEth) and comprises an inhibitor of the enzyme phospholipase D immobilized in the test tube, is not persuasive inasmuch as the intended use of the device does not structurally distinguish over Ugwuanyi et al. and Campbell et al. who disclose test tubes that contain sodium tungstate.
Applicant’s argument that Carroll et al. is silent regarding the inhibition of any enzyme is not persuasive since Ugwuanyi et al. and Campbell et al. both teach sodium tungstate.
Applicant’s argument that Ugwuanyi et al. does not teach why sodium tungstate is used is not germane since Ugwuanyi et al. nevertheless teaches sodium tungstate.
Applicant’s argument that a person of ordinary skill in the art faced with the problem of how to provide an improved tube for testing the concentration of PEth in a blood sample would not find any teachings, suggestions or motivation in Carroll, Campbell and/or Ugwuanyi or any combination thereof that would lead the artisan to modify the test tube such that it comprised an inhibitor of PLD immobilized in the test tube, overlooks that Ugwuanyi et al. and Campbell et al. both teach sodium tungstate and Carroll et al. teaches applying necessary reagents as coatings in test tubes.
Allowable Subject Matter
Claim 21 is allowed.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance:
The prior art of record does not teach analyzing samples or preparing samples for analysis of phosphatidylethanol (PEth).
Method claims directed to the collection and testing of phosphatidylethanol (PEth) in a blood sample that recite the method steps of claim 21 together with a method step of providing the device of claim 12, would distinguish over the prior art of record.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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/M.S.G./Examiner, Art Unit 1798
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798