DETAILED ACTION
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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, and 15 is rejected under 35 U.S.C. 103 as being unpatentable over Milgrom (YouTube video published November 10, 2017 https://www.youtube.com/watch?v=-OPWx9oKoio) in view of Labib (US Publication U.S. Publication 2015/0314057).
Regarding claim 1, Milgrom teaches introducing a volume of the blood into a blood container (see YouTube screenshot annotated figure below which shows blood going from a patient into the container); and moving the container in a rotary orbital motion (the YouTube video shows the container moving in a rotary orbital motion) using an orbital vortex motor to generate a sinusoidal wave in the moving blood (see housing for the orbital vortex motor, which is considered inherently requiring generating a sinusoidal wave to obtain the rotary orbital motion). Regarding claim 1, Milgrom is silent to a method for maintaining blood in a state of laminar hemodynamic flow over a blood-contacting surface and substantially free of coagulating blood and/or particulate precipitation thus establishing a laminar flow of the blood in the blood container and over the blood contacting surface. Regarding claim 1, Labib teaches a method for maintaining blood in a state of laminar hemodynamic flow (paragraph 126 teaches laminar flow) and substantially free of coagulating blood and/or particulate precipitation (paragraph 322 teaches using anti-coagulant which is considered reading on substantially free of coagulating blood) thus establishing a laminar flow of the blood in the blood container and over the blood contacting surface (paragraph 126 teaches laminar flow along the length of the fiber bundle) with a sinusoidal flow path (paragraph 19 teaches a sinusoidal flow path). Regarding claim 1, it would have been obvious to modify the method of Milgrom with the flow and coagulating free blood and laminar flow to obtain the desired blood treatment for the patient. Both references are considered in the same field of endeavor since they are concerned with treatment of extracorporeal blood.
Regarding claim 2, Milgrom teaches wherein the volume of the blood is introduced into the blood container by connecting an intravenous (IV) tube from a vein of a human patient to an inlet of the blood container (see screenshot which shows an intravenous tube), and applying suction pressure to a port of the blood container to accumulate a desired volume of the blood in the blood container while the orbital vortex motor moves the container in the rotary orbital motion (see screenshot which shows blood being delivered to the port of the container while the container is in rotary orbital motion, the motion of blood through the tube would inherently require a pressure drop in the form of suction pressure).
Regarding claim 3, Milgrom teaches further comprising subsequently removing the suction pressure responsive to the accumulation of the desired volume of the blood in the blood container (before too much blood is extracted from the patient, the suction of blood would inherently have to stop) and activating an ozonation device to introduce a mixture of oxygen and ozone into the blood container during continued movement of the container in the rotary orbital motion by the orbital vortex motor (the title of Milgrom teaches ozone therapy which would inherently require the delivery of ozone during the rotary orbital motion by the container).
Regarding claim 4, Milgrom teaches further comprising subsequently deactivating the ozonation device and supplying a positive pressure to a port of the blood container to pump the blood in the blood container back into the vein of the human patient using the IV tube and the inlet of the blood container during continued movement of the container in the rotary orbital motion by the orbital vortex motor (in order for the ozone therapy to work, the blood must be delivered back to the patient after the desired ozone level is achieved which would inherently require shutting down the ozonation device).
Regarding claim 5, Milgrom teaches further comprising repeating the applying, removing activating, deactivating, and supplying steps a selected plural number of passes in succession (the description of Milgrom teaches 10 passes).
Regarding claim 6, Milgrom teaches wherein the selected plural number is at least 10 (the description of Milgrom teaches 10 passes).
Regarding claim 7, while Milgrom teaches 10 passes (see description of the YouTube link) Milgrom is silent to the volumes of each pass. Regarding claim 10, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to choose the desired volume to obtain the desired ozone level in the blood since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 9, Milgrom teaches further comprising introducing a pharmaceutical compound into the blood container during continued movement of the container in the rotary orbital motion by the orbital vortex motor (see description of the YouTube video which teaches blood with ozone, which is considered reading on a pharmaceutical compound).
Milgrom is silent to the language of claim 10. Regarding claim 10, Labib teaches an anticoagulant (paragraph 488 teaches the use of anticoagulant). It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the treatment of Milgrom with the anticoagulant of Labib in order to obtain the desired treatment for the patient.
Regarding claim 11, Milgrom is silent to no pharmaceutical component is introduced into the blood container during continued movement of the container in the rotary orbital motion by the orbital vortex mixer. Regarding claim 11, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to omit a specific pharmaceutical compound in order to obtain the desired treatment for the patient since it has been held that omission of an element and its function in a combination where the remaining elements perform the same functions as before involves only routine skill in the art. In re Karlson, 136 USPQ 184.
Regarding claim 12, Milgrom teaches wherein the container is a rigid container having an oblate spheroid, circular cylindrical or circular conical shape (see screenshot provided, the container is rigid and has an oblate spheroid shape).
Milgrom is silent to the size of the motion (which would inherently affect the size of the orbital path) of claim 13. Regarding claim 13, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shape of the apparatus in order to obtain the desired degree of agitation since it is well settled that it is an obvious matter of design choice to change the general shape or size of a known element in the absence of a disclosed non-obvious advantage associated with the change. Gardner vs. TEC Systems Inc., 725 F.2d 1338, 1349-50 (Fed. Cir. 1984); In re Kuhle, 526 F.2d 553, 555 (CCPA 1975); In re Dailey, 357 F.2d 669, 672 (CCPA 1966).
Regarding claim 14, Milgrom teaches a rotating container (see YouTube link, which shows the container rotating in an orbital path). Regarding claim 14, Milgrom is silent to the specific rotations. Regarding claim 14, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the rotation amount in order to obtain the desired degree of agitation in the blood since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 15, Milgrom is silent to the specific material of the container. Regarding claim 15, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to try using a different material such as glass or plastic in order to obtain the desired weight and rigidity of the container.
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Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 8, the prior art does not teach the method of maintaining blood in a laminar state with the combination of the ozonation device and the filter wherein the filter remains submerged in blood.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANSHU BHATIA whose telephone number is (571)270-7628. The examiner can normally be reached Monday - Friday 11 a.m. to 7:30 p.m..
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/ANSHU BHATIA/Primary Examiner, Art Unit 1774
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