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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the warming of the ozonated blood in a blood flow exiting the apparatus upstream of a location of the injection of ozone as in claim 4 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: paragraph [0053] describes warming means downstream of the ozonation chamber, whereas claim 4 describes warming upstream of a location of the injection of ozone.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains the phrase "Figure to be published with the abstract: Fig. 1". A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
Reference number 2 refers to an ozonation chamber in paragraphs [0025], [0030], [0035], [0036], [0049], [0050], [0052], [0053], [0065.
Paragraph [0047] “heart and lunch machine” should read “heart and lung machine”.
Appropriate correction is required.
Claim Objections
Claim 18 is objected to because of the following informalities:
Claim 18 "heart and lunch machine" should read "heart and lung machine".
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cordemans (WO 2004041314).
Regarding claim 1, Cordemans teaches a method for contacting blood with ozone (para [0027]. [0016] physiological fluid in which hyperproliferative cells are suspended includes blood), the method comprising:
receiving a flow of blood into an ozonation apparatus (para [0051]);
injecting bubbles of an ozone containing gas into the flow of blood (para [0037]); and
delivering the flow of blood that is ozonated from the ozonation apparatus (para [0020]);
wherein the flow of blood is vertically upwards during the injecting of bubbles of the ozone containing gas (para [0027] and Fig. 1).
Regarding claim 20, Cordemans teaches a method for contacting blood with ozone (para [0027]), the method comprising:
receiving a flow of blood into an ozonation apparatus (para [0051]);
directing the flow of blood vertically upwards (para [0027] and Fig. 1);
injecting bubbles of an ozone containing gas into the flow of blood directed vertically upwards (para [0037] injection of ozone, para [0027] and Fig. 1 vertically upwards); and
delivering the flow of blood that is ozonated from the ozonation apparatus (para [0020]).
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 2 and 3 and are rejected under 35 U.S.C. 103 as being unpatentable over Cordemans (WO 2004041314) in view of Sjoholm (WO 2008066470) and further in view of Patterson (US 6565807).
Regarding claim 2, Cordemans teaches the method of claim 1. Cordemans does not teach cooling the flow of blood to a temperature of less than 12°C before the receiving of the blood flow. However, Sjoholm teaches cooling a flow of a liquid medium to a temperature of less than 12°C before the receiving of the liquid (p 16 lines 15-17 during transport and storage). Sjoholm further teaches that the liquid to be treated should preferably have a temperature of less than 20 °C (p 10 lines 16-21). Sjoholm is considered analogous art in that it teaches ozonation of a biological liquid medium which can include blood (p 11 lines 25-28, p 10 lines 16-21). Sjoholm does not teach why it is preferable at that temperature range. However, Patterson teaches solubility of gasses in liquids such as blood increases at lower temperatures (col 12 lines 34-39). Therefore, it would have been obvious to someone of ordinary skill in the art to modify the teachings of Cordemans by cooling the blood before receiving it in the apparatus as suggested by Sjoholm and Patterson.
Regarding claim 3, Cordemans teaches the method of claim 1. Cordemans does not teach cooling the blood in the flow of blood upstream of a location of the injection of ozone to a temperature of less than 12°C during the injecting of ozone. However, Sjoholm teaches cooling the blood to a temperature of less than of less than 12°C (p 10 lines 16-21, p 16 lines 15-17 during transport and storage). Sjoholm does not teach the cooling during the injection of ozone. However, Patterson teaches solubility of gasses in liquids such as blood increases at lower temperatures (col 12 lines 34-39). Therefore, it would have been obvious to someone of ordinary skill in the art to modify the teaching of Cordemans by cooling the blood during injection of ozone as suggested by Sjoholm and Patterson.
Claims 5, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Cordemans (WO 2004041314) in view of Sjoholm (WO 2008066470).
Regarding claim 5, Cordemans teaches the method of claim 1. Cordemans does not teach wherein injecting the bubbles further comprises injecting microbubbles that have a mean diameter of less than 5 µm. However, Sjoholm teaches injecting microbubbles that have a mean diameter of less than 5 µm (p 8 lines 25-30). Sjoholm teaches that extremely small ozone gas bubbles increase the efficiency of mixing (p 14 lines 7-14). Therefore, it would have been obvious to someone of ordinary skill in the art to modify the teachings of Cordemans with the microbubble diameter taught by Sjoholm.
Regarding claim 8, Cordemans teaches the method of claim 1. Cordemans does not teach dissolving the bubbles completely in the flow of blood less than 10 seconds after the injecting for the ozonation of the blood. However, Sjoholm teaches dissolving the bubbles completely in the flow less than 10 seconds after the injecting for the ozonation (p 8 lines 30-34). Cordemans teaches that the blood can be effectively treated in short periods of time including between 5-20 seconds (para [0035]) which overlaps with the less than 10 seconds taught by Sjoholm. Therefore, it would have been obvious to someone of ordinary skill in the art to modify the teachings of Cordemans with the dissolving time as taught by Sjoholm.
Regarding claim 9, Cordemans teaches the method of claim 1. Cordemans does not teach injecting the ozone containing gas into the flow of blood at a pressure of less than 1 bar. However, Sjoholm teaches injecting the ozone containing gas into the flow of blood at a pressure of less than 1 bar (p 8 lines 14-15). Sjoholm teaches this pressure produces optimal gas bubbles into the liquid (p 10 lines 16-21). Therefore, it would have been obvious to someone of ordinary skill in the art to modify the teachings of Cordemans with the pressure taught by Sjoholm.
Claims 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Cordemans (WO 2004041314) in view of Patterson (US 6565807) and Latino (US 20050051497).
Regarding claim 4, Cordemans teaches the method of claim 1. Cordemans does not teach warming the ozonated blood in a flow of blood exiting the apparatus upstream of a location of the injection of ozone. However, Patterson further teaches warming the ozonated blood in a blood flow exiting the apparatus (col 19 lines 25-32). Patterson teaches that temperature of the returning blood can affect a patient’s core temperature and is best returned at 37 °C to have no significant effect in a patient’s temperature (col 11 lines 55- col 12 line 16). Patterson does not teach that this warming is upstream of a location of the injection of ozone. However, Latino teaches that blood can be circulated through the apparatus multiple times or in a series of apparatuses, therefore making the warming of the blood exiting the apparatus upstream of a location of an injection of ozone (para [0097], para [0121] -[0122]). Therefore, it would have been obvious to someone of ordinary skill in the art to modify the teaching of Cordemans by heating the blood exiting the apparatus as suggested by Patterson and Latino.
Regarding claim 7, Cordemans teaches the method of claim 1. Cordemans does not teach a flow rate of blood or ozone containing gas. However, Latino teaches wherein the flow of blood during the injecting is from about 0.1 Liters/hour to about 10 Liters/hour (para [0097] wherein 1 mL/minute is 0.06 Liters/hour and 100 liters per minute is 6 Liters/hour). Latino does not teach the flow rate of ozone containing gas. However, Patterson teaches a flow rate of the gas is about 0.01 Liters per hour to about 1 Liter per hour (col 11 lines 30-42 wherein 0.1cc/min is 0.12 liters per hour and 12 cc/min is 0.72 liters per hour). Therefore, it would have been obvious to someone of ordinary skill in the art to modify the teachings of Cordemans with the flow rates of blood and ozone as taught by Latino and Patterson.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Cordemans (WO 2004041314) in view of Latino (US 20050051497) and “Scientific and Medical Aspects of Ozone Therapy. State of the Art” referred to herein as Bocci.
Regarding claim 6, Cordemans teaches the method of claim 1. Cordemans does not teach a concentration of ozone in the ozone containing gas, or that it comprises less than 10 grams of ozone per cubic meter or wherein the ozone containing gas comprises 5% to 20% ozone by weight and 95% to 80% oxygen by weight. However, Latino further teaches wherein the ozone containing gas comprises less than 10 grams of ozone per cubic meter ([0017] defines 1 ppmv as 0.00214 micrograms ozone per mL oxygen, which is known to be equivalent to 0.00214 grams per cubic meter, [0137] shows the lowest concentration used of 300 ppmv or 0.642 grams per cubic meter and [0147] shows the highest concentration used of 1000 ppmv or 2.14 grams per cubic meter). Bocci teaches that higher concentrations of ozone leads to incipient hemolysis indicating the start of ozone toxicity (p 430 col 2 para 2). Therefore, it would have been obvious to someone of ordinary skill in the art to modify the method of Cordemans with the ozone concentration taught by Latino and Bocci.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Cordemans (WO 2004041314) in view of Latino (US 20050051497) and Spears (WO 9214404).
Regarding claim 10, Cordemans teaches the method of claim 1. Cordemans does not teach injection pressure or flow rates of blood or ozone. However, Latino teaches adjusting 1) a flow rate of the blood, 2) an injection pressure of ozone containing gas, and/or 3) a flow rate of ozone containing gas (para [0078]- [0098], fluid includes blood [0047]). Latino does not explicitly teach preventing or minimizing a coalescence of bubbles during the injecting bubbles of the ozone containing gas by the adjusting. However, Spears teaches preventing or minimizing a coalescence of bubbles during the injecting bubbles of a gas into blood at sufficient velocities (p 17 lines 9-20). Spears provides motivation to minimize coalescence of bubbles in blood because coalescence creates foaming and resultant occlusion of pulmonary arterioles (p 21 lines 18-35). Therefore, it would have been obvious to someone of ordinary skill in the art to modify the method of Cordemans with the adjusting of variables as taught by Latino to minimize Coalescence as taught by Spears.
Claims 11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cordemans (WO 2004041314) in view of Latino (US 20050051497).
Regarding claim 11, Cordemans teaches the method of claim 1. Cordemans teaches performing in vitro ozonation of the blood in one embodiment (para [0020], [0060]). Cordemans does not explicitly describe this as in vitro ozonation. However, Latino defines in vitro as use of a material as outside a living human, mammal, or vertebrate (para [0033]). Latino is considered analogous art in that Latino also teaches ozonation of blood (para [0047], [0066]). Cordemans teaches use of a material as outside a living human, mammal, or vertebrate (para [0020] reservoir is not connected to an animal or human, [0049]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date to conclude that the teachings of Cordemans comprises in vitro ozonation of the blood as defined by Latino.
Regarding claim 13, Cordemans and Latino teach the method of claim 11, and Latino further teaches the in-vitro ozonation of the blood is made after storage of the blood and/or before administration of the blood to a patient (para [0054], para [0055] ozone inactivates viruses).
Regarding claim 14, Cordemans teaches the method of claim 1. Cordemans teaches performing in vivo ozonation of the blood in one embodiment (para [0020]). Cordemans does not explicitly describe this as in vivo ozonation. However, Latino defines in vivo as use of a material as introducing the material or compound into a living human, mammal, or vertebrate (para [0032]). Cordemans teaches use of a material as introducing the material or compound into a living human, mammal, or vertebrate (para [0020] includes administering the blood). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date to conclude that the teachings of Cordemans comprises in vivo ozonation of the blood as defined by Latino.
Regarding claim 15, Cordemans and Latino teach the method of claim 14, and Latino further teaches performing therapeutic or preventive treatment of a patient (para [0053]).
Regarding claim 16, Cordemans and Latino teach the method of claim 14, and Latino further teaches extracting blood from a patient, ozonating the blood, and feeding back the ozonated blood to the patient (para [0111]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Cordemans (WO 2004041314) in view of Latino (US 20050051497) and further in view of Sjoholm (WO 2008066470).
Regarding claim 12, Cordemans and Latino teach the method of claim 11. Cordemans and Latino do not expressly teach wherein the in-vitro ozonation of the blood is made prior to storage of the blood. However, Sjoholm teaches in-vitro ozonation of the blood is made prior to storage of the blood and providing enhanced storage time of the ozonated blood compared to the blood when not ozonated (p 11 lines 25-28 blood can be used, p 7 lines 28-37 inhibit bacterial growth in biological liquid media, p 6 lines 4-7 lowered bacterial count increases shelf life). Therefore, it would have been obvious to someone of ordinary skill in the art that ozonation prior to storage increases storage time as taught by Sjoholm.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cordemans (WO 2004041314) in view of Latino (US 20050051497) in further view of Diang (DE 20116498, machine translation copy provided).
Regarding claim 17, Cordemans and Latino teach the method of claim 14. Latino teaches that fluids used for peritoneal dialysis may benefit from the ozonation treatment because it can be contaminated (para [0044]), but fails to teach performing dialysis treatment of the flow of blood of a patient. However, Diang teaches ozone hemodiafiltration in a dialyzer (p 2 para 2-4) for its sterilizing effect (p 1 para 1). Therefore, it would have been obvious to someone of ordinary skill in the art to modify the teaching of Cordemans by performing dialysis as suggested by Latino and Diang.
Regarding claim 18, Cordemans and Latino teach the method of claim 14. They do not explicitly teach ozonation of the blood in a flow of blood in an apheresis machine, dialysis machine, or heart and lunch machine. However, Diang teaches ozone hemodiafiltration in a dialyzer (p 2 para 2-4) for its sterilizing effect (p 1 para 1). Therefore, it would have been obvious to someone of ordinary skill in the art to modify the teaching of Cordemans by performing ozonation in a dialysis machine as suggested by Latino and Diang.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Cordemans (WO 2004041314) in view of Patterson (US 6565807) and “Scientific and Medical Aspects of Ozone Therapy. State of the Art” referred to herein as Bocci.
Regarding claim 19, Cordemans teaches a method for contacting blood with ozone (para [0040]), the method comprising:
receiving a flow of blood into an ozonation apparatus (para [0051]);
reducing or avoiding foaming of the flow of blood by injecting bubbles of an ozone containing gas into the flow of blood such that the ozone containing gas entrains within the flow of blood (para [0027]); and
delivering the flow of blood that is ozonated from the ozonation apparatus (para [0020]).
Cordemans does not explicitly teach that the ozone containing gas dissolves within the flow of blood. However, Patterson teaches dissolving of gas in a flow of blood (col 8 lines 54 - col 9 line 3). Patterson teaches that dissolving of the gas prevents clinically significant gas bubbles (col 6 lines 24-38) which can embolize and cause life threatening complications if large enough (col 16 lines 21-50). Patterson does not teach that this gas comprises ozone. However, Bocci teaches ozone is capable of dissolving in blood (abstract). Therefore, it would have been obvious to someone of ordinary skill in the art that injecting ozone into blood will dissolve ozone in the flow of blood as suggested by Bocci and Patterson.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLEIGH K KAWECKI whose telephone number is (571)272-1784. The examiner can normally be reached Monday - Friday 8:30 am - 12:00, 1:00 - 5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached on (571) 270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MKK/Examiner, Art Unit 1779
/Bobby Ramdhanie/Supervisory Patent Examiner, Art Unit 1779