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 .
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7,16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over [Otto et al. US 20120226258 hereafter Otto, in view of Kroon et al. US 2006/0045853, provided in the previous office action.
Regarding claim 1, Otto discloses
An extracorporeal apparatus for blood and blood product pheresis (abstract, para. 0017,0025), wherein said apparatus comprises, either comprises, at least in part at least one molecule that specifically binds tissue plasminogen activator (tPA) and plasminogen (para. 0089). The examiner notes that per paragraph 0089, the extracorporeal circuit uses a priming fluid which mixes in with the blood circulation of the patient may comprise tranexamic acid. The examiner notes however, that the disclosure of Otto is broad and thus does not specifically teach that said acid is bound to a solid support, or coats the device. Otto does teach that, per para. 0092, the device is used to remove toxins from blood, including biological substances, such as fibrin, antibodies, proteins, and more. See also para. 0098. Otto further teaches that said ECMO device functions in combination with hemofiltration (para. 0027), where the oxygenation and/or filtration membrane is coated with endotoxin binding substances (para. 0027). The examiner notes that as previous stated, toxins included biological substances (per para. 0092). Thus if fibrinogen is the desired toxin removed, a fibrinogen binding or inhibiting agent would be provided on the filter. However, no specific tPA or plasminogen binding is disclosed.
Kroon teaches an extracorporeal apparatus for blood and blood product pheresis and is thus considered analogous to the claimed invention. Kroon teaches wherein said apparatus comprises, at least in part, by at least one molecule that specifically binds tissue plasminogen activator (tPA) and plasminogen (para. 0028). Kroon also teaches that tPA activity is increased by binding to fibrin (para. 0025,0026). Therefore, as tPA and plasminogen, alone or in combination with fibrin is undesirable in blood due to the effects of tPA activity (see para. 0008 of Kroon), where compounds such as tranexamic acid are used to bind to tPA to prevent said activity, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the blood filter of Otto with such a compound (tranexamic acid) to bind to and inhibit tPA activity, as the device of Otto is configured to remove toxins, including biological toxins, from the blood being passed through said filter. Doing so would merely involve applying a known technique (tranexamic compounds for inhibiting tPA) to a known device (extracorporeal blood filter for toxins) ready for improvement to yield predictable results (the binding of tPA known to be undesirable in blood);
Regarding claim 2, Otto and Kroon teach
The extracorporeal apparatus according to claim 1, wherein the molecule that specifically binds tPA and plasminogen is 4-(aminomethyl)-cyclo- hexane-carboxylic acid (tranexamic acid). Per the rejection of claim 1, tranexamic acid can be used for such treatment.
Regarding claim 3, Otto and Kroon teach
The extracorporeal apparatus according to claim 1, wherein the molecule that specifically binds tPA and plasminogen is tranexamic acid. Per the rejection of claim 1, tranexamic acid can be used for such treatment.
Regarding claim 4, Otto and Kroon teach
The extracorporeal apparatus according to claim 1, wherein said apparatus comprises a filter. The examiner notes that as detailed under the rejection of claim 1, Otto teaches a filter coating in toxin removing material to remove toxins from blood passing through. Thus the combination comprises a filter.
Regarding claim 5, Otto and Kroon teach
The extracorporeal apparatus according to claim 1, wherein said apparatus is adapted for affinity depletion procedure specific for t-PA and plasminogen from a blood and/or blood-derived product. As detailed above under the rejection of claim 1, the device treats blood flowing through a filter by binding and thus removing tPA or tPA-like substances, per Otto in view of Kroon. Therefore as tranexamic acid is known to bind and inhibit tPA, using said acid in the unit of the combination would have the same effect. Should applicant disagree with the interpretation, the examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Otto in view of Kroon teaches a blood pheresis system in which tranexamic acid, known to bind to tPA, is used to treat the blood, it is interpreted that the device performs an affinity depletion procedure.
Regarding claim 6, Otto and Kroon teach
The extracorporeal apparatus according to claim 5, wherein said depletion procedure results in a blood and/or blood-derived product that has a reduced fibrinolytic activity. The examiner notes that as tranexamic acid is used in the system, the derived product would have reduced fibrinolytic activity. Should applicant disagree with the interpretation, the examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Otto in view of Kroon teaches a blood pheresis system in which tranexamic acid, known to bind to tPA, is used to treat the blood, it is interpreted that the device provides a product with reduced fibrinolytic activity, as the same binding agent as the claimed limitation is being used to treat the blood.
Regarding claim 7, Otto and Kroon teach
The extracorporeal apparatus according to claim 6, wherein said blood or a blood- derived product has decreased R-value in thromboelastography (TEG) analysis, as compared to blood or blood-derived product not subjected to said depletion procedure. The examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Otto in view of Kroon, teaches a blood pheresis system in which tranexamic acid, known to bind to tPA, is used to treat the blood per the claimed limitation, it is interpreted that the product would have a reduced R-value in TEG analysis, as the same binding agent as the claimed limitation is being used to treat the blood.
Regarding claim 16, Otto and Kroon teach
A method for performing an extracorporeal procedure in a subject in need thereof, the method comprising the steps of (i) transferring blood of said subject into an extracorporeal apparatus, as defined by claim 1; (ii) subjecting said blood to affinity depletion procedure specific for tPA and plasminogen, wherein said depletion is performed before, during or after blood is transferred into and out-off said apparatus, thereby obtaining an extracorporeal tPA-deficient and plasminogen deficient blood and/or blood- derived product of said subject; and optionally (iii) returning the t-PA and plasminogen-deficient blood or plasma obtained in step (ii) to said subject. Para. 0042-0043. The examiner notes that per para. 0043, the blood is taken from the patient, treated per the system disclosed in claim 1, and returned to the patient. Per the rejection of claim 1, as the treatment involves the decreasing of tPA activity due to binding with tranexamic acid, the step of treating the blood in the prior art would produce a product with tPA and plasminogen deficient blood, which is then returned to the patient, thus completing step iii as claimed.
Regarding claim 17, Otto and Kroon teach
The method according to claim 16, wherein said affinity depletion procedure of tPA and plasminogen is performed by contacting said blood with at least one molecule that specifically binds at least one of tPA and/or plasminogen, optionally, wherein the molecule that specifically binds tPA and plasminogen is: 4-(aminomethyl)- cyclo- hexane-carboxylic acid (tranexamic acid). The examiner notes that as detailed under the rejection of claim 1 and 16, tranexamic acid is used for the treatment.
Regarding claim 18, Otto and Kroon teach
A method for the treatment, amelioration, or inhibition of bleeding in a subject having a hemostatic disorder or any bleeding or pathologic condition associated therewith, by administering to said subject a therapeutically effective amount of a blood and/or blood-derived product that was subjected to affinity depletion procedure specific for t-PA and plasminogen, and display a reduced fibrinolytic activity, wherein said affinity depletion procedure is performed using the apparatus according to claim 1. The examiner notes that as detailed under the rejection of claim 1, Otto in view of Kroon discloses an blood treatment unit for treating a patient where Kroon discloses that tranexamic acid that it is a known treatment method and therefore would be obvious to use with such a system. The examiner notes that tranexamic acid is known the bind to tPA to inhibit tPA activity. Therefore using said acid in the unit of the combination would provide an affinity depletion procedure. Should applicant disagree with the interpretation, the examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Otto in view of Kroon teaches a blood pheresis system in which tranexamic acid, known to bind to tPA, is used to treat the blood, it is interpreted that the device performs an affinity depletion procedure.
Further, Otto para. 0102 teaches that operation of the system allows for prevention, alleviation or treatment of diseases, including pathologic conditions such as sepsis and more (para. 0104). Sepsis is a pathologic induced blood condition and is thus interpreted to read to claimed invention.
Regarding claim 19, Otto and Kroon teach
The method of claim 18, wherein said affinity depletion procedure comprises the steps of (i) transferring blood of said subject into said extracorporeal apparatus; (ii) subjecting said blood to affinity depletion procedure specific for tPA and plasminogen, wherein said depletion is performed before, during or after blood is transferred into and out-off said apparatus, thereby obtaining an extracorporeal tPA-deficient and plasminogen deficient blood and/or blood- derived product of said subject; and (iii) returning the t-PA and plasminogen-deficient blood or plasma obtained in step (ii) to said subject. Para. 0042-0043. The examiner notes that per para. 0043, the blood is taken from the patient, treated per the system disclosed in claim 1, and returned to the patient. Per the rejection of claim 1, as the treatment involves the decreasing of tPA activity due to binding with tranexamic acid, the step of treating the blood in the prior art would produce a product with tPA and plasminogen deficient blood, which is then returned to the patient, thus completing step iii as claimed.
Regarding claim 20, Otto and Kroon teach
The method according to claim 18, wherein said hemostatic disorder is hereditary or acquired bleeding disorder, optionally wherein at least one of (a) said hereditary hemostatic disorder is a disorder resulting from at least one of deficiency in at least one coagulation factor and undefined tendency to bleeding; (b) said acquired hemostatic disorder is at least one of surgery-induced bleeding, trauma-induced bleeding, acute gastrointestinal bleeding, bleeding associated with burns, hemorrhagic stroke, lung injury due to emphysema and Chronic Obstructive Pulmonary Disease (COPD), bleeding associated with childbirth and bleeding resulting from fibrinolytic or thrombolytic therapy. Per para. 0039, the system of Kroon is used for various disorders in addition to bleeding, and therefore reads to the claim. Thus it would be used to use the treatment method as applied to Otto per the rejection of claim 18, for use in treating bleeding or other diseases.
Claim(s) 8-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Otto in view of Kroon and further in view of / evidenced by Cauley et al. US 2010/0125235, hereafter Cauley.
Regarding claim 8, Otto and Kroon teach
The extracorporeal apparatus according to claim 1, wherein said apparatus is, or comprises at least one apheresis unit for blood and blood product pheresis (para. 0005). The examiner notes that Otto para. 0005, teaches that apheresis units were, or are, commonly used with other extracorporeal procedures. However, should applicant disagree, the examiner provides a rejection in view of evidence from Cauley.
Cauley teaches a blood treatment apparatus and is thus considered analogous to the claimed invention. Cauley teaches that “Apheresis is the process of removing a specific component from blood and returning the remaining components to a blood donor or patient” (para. 0011), where one form of apheresis is carried out using a hemofiltration device (para. 0011). Therefore, as Cauley teaches that apheresis is the process of removing specific components from blood and returning the components back to the patient, sometimes done with a hemofilter, and Otto in view of Kroon teaches the removal of certain components (toxins) from blood going back into a patient using a filter, it is interpreted that Otto in view of Kroon are or comprise an apheresis unit (in view of the filter) as said device performs the function of an apheresis unit as taught by Cauley.
Regarding claim 9, Otto and Kroon teach
The extracorporeal apparatus according to claim 1, the extracorporeal apparatus is a cardiopulmonary bypass machine (CPB), or a plasmapheresis machine. The examiner notes that Otto para. 0005, teaches that apheresis units were, or are, commonly used with other extracorporeal procedures, and para. 0031 of Otto teaches that plasma may be the material run through the system. However, should applicant disagree, the examiner provides a rejection in view of evidence from Cauley.
Cauley teaches a blood treatment apparatus and is thus considered analogous to the claimed invention. Cauley teaches that “Apheresis is the process of removing a specific component from blood and returning the remaining components to a blood donor or patient” (para. 0011), where one form of apheresis (plasmapheresis) is carried out using a hemofiltration device (para. 0011). Therefore, as Cauley teaches that apheresis is the process of removing specific components from blood and returning the components back to the patient, sometimes done with a hemofilter (in plasmapheresis), and Otto in view of Kroon teaches the removal of certain components (toxins) from blood and/or plasma going back into a patient using a filter, it is interpreted that Otto in view of Kroon are or comprise a plasmapheresis unit (in view of the filter) as said device performs the function of such a unit as taught by Cauley.
Regarding claim 10, Otto discloses
An unit for blood and blood product pheresis ((abstract, para. 0017,0025)), however fails to specifically disclose adapted for affinity depletion procedure specific for t-PA and plasminogen, wherein said affinity-depletion procedure uses a molecule that specifically binds tPA and plasminogen, The examiner notes however, that the disclosure of Otto is broad and thus does not specifically teach that said acid is bound to a solid support, or coats the device. Otto does teach that, per para. 0092, the device is used to remove toxins from blood, including biological substances, such as fibrin, antibodies, proteins, and more. See also para. 0098. Otto further teaches that said ECMO device functions in combination with hemofiltration (para. 0027), where the oxygenation and/or filtration membrane is coated with endotoxin binding substances (para. 0027). The examiner notes that as previous stated, toxins included biological substances (per para. 0092). Thus if fibrinogen is the desired toxin removed, a fibrinogen binding or inhibiting agent would be provided on the filter. However, no specific tPA or plasminogen binding is disclosed.
Kroon teaches an extracorporeal apparatus for blood and blood product pheresis and is thus considered analogous to the claimed invention. Kroon teaches wherein said apparatus comprises, at least in part, by at least one molecule that specifically binds tissue plasminogen activator (tPA) and plasminogen (para. 0028). Kroon also teaches that tPA activity is increased by binding to fibrin (para. 0025,0026). Therefore, as tPA and plasminogen, alone or in combination with fibrin is undesirable in blood due to the effects of tPA activity (see para. 0008 of Kroon), where compounds such as tranexamic acid are used to bind to tPA to prevent said activity, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the blood filter of Otto with such a compound (tranexamic acid) to bind to and inhibit tPA activity, as the device of Otto is configured to remove toxins, including biological toxins, from the blood being passed through said filter. Doing so would merely involve applying a known technique (tranexamic compounds for inhibiting tPA) to a known device (extracorporeal blood filter for toxins) ready for improvement to yield predictable results (the binding of tPA known to be undesirable in blood). Said combination still fails to specifically disclose that the device is adapted for affinity depletion procedure specific for t-PA and plasminogen from a blood and/or blood-derived product. As detailed above under the same rejection, the device treats blood flowing through a filter by binding and thus removing tPA or tPA-like substances, per Otto in view of Kroon. Therefore as tranexamic acid is known to bind and inhibit tPA, using said acid in the pheresis unit of the combination would have the same effect. Should applicant disagree with the interpretation, the examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Otto in view of Kroon teaches a blood pheresis system in which tranexamic acid, known to bind to tPA, is used to treat the blood, it is interpreted that the device performs an affinity depletion procedure.
Further, while the device fails to specifically discloses an apheresis unit, Otto para. 0005, teaches that apheresis units were, or are, commonly used with other extracorporeal procedures. However, should applicant disagree, the examiner provides a rejection in view of evidence from Cauley.
Cauley teaches a blood treatment apparatus and is thus considered analogous to the claimed invention. Cauley teaches that “Apheresis is the process of removing a specific component from blood and returning the remaining components to a blood donor or patient” (para. 0011), where one form of apheresis is carried out using a hemofiltration device (para. 0011). Therefore, as Cauley teaches that apheresis is the process of removing specific components from blood and returning the components back to the patient, sometimes done with a hemofilter, and Otto in view of Kroon teaches the removal of certain components (toxins) from blood going back into a patient using a filter, it is interpreted that Otto in view of Kroon are or comprise an apheresis unit (in view of the filter) as said device performs the function of an apheresis unit as taught by Cauley.
Regarding claim 11, Otto, Kroon, and Cauley teach
The apheresis unit according to claim 10, wherein said unit comprises, at least in part, by tranexamic acid that specifically binds at least one of tPA and plasminogen. Per the rejection of claim 10, tranexamic acid can be used for such treatment.
Regarding claim 12, Otto, Kroon, and Cauley teach
The apheresis unit according to claim 10, wherein the apheresis unit further comprises a filter. The examiner notes that as detailed under the rejection of claim 1, Otto teaches a filter coating in toxin removing material to remove toxins from blood passing through. Thus the combination comprises a filter.
Regarding claim 14, Otto, Kroon, and Cauley teach
The apheresis unit according to claim 13, wherein said depletion procedure results in a blood and/or blood-derived product that has a reduced fibrinolytic activity. The examiner notes that as tranexamic acid is used in the system, the derived product would have reduced fibrinolytic activity. Should applicant disagree with the interpretation, the examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Otto in view of Kroon teaches a blood pheresis system in which tranexamic acid, known to bind to tPA, is used to treat the blood, it is interpreted that the device provides a product with reduced fibrinolytic activity, as the same binding agent as the claimed limitation is being used to treat the blood.
Regarding claim 15, Otto, Kroon, and Cauley teach
The apheresis unit according to claim 14, wherein said blood or a blood-derived product has decreased R-value in thromboelastography (TEG) analysis, as compared to blood or blood-derived product not subjected to said depletion procedure. The examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Otto in view of Kroon, teaches a blood pheresis system in which tranexamic acid, known to bind to tPA, is used to treat the blood per the claimed limitation, it is interpreted that the product would have a reduced R-value in TEG analysis, as the same binding agent as the claimed limitation is being used to treat the blood.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Otto in view of Kroon and further in view of Nur et al. US 2003/0124703, hereafter Nur.
Regarding claim 21, Otto and Kroon teach
The extracorporeal apparatus according to claim 1, wherein said extracorporeal apparatus further comprises a filter containing tranexamic acid (see claim 1 rejection). However said combination of arts fail to teach that the tranexamic acid is linked to a solid support.
Nur teaches a blood treatment system(para. 0017) and is thus considered analogous to the claimed invention. Nur teaches that studies were conducted showing that tranexamic acid bound to solid supports aid in removal of plasminogen from plasma (para. 0010), and that in studies conducted under Nur (para. 0014), tranexamic acid resin affinity is not effected, despite tranexamic acid losing its extra affinity when bound to a solid surface. The examiner notes that this binding causes tranexamic acid to lose its extra affinity. As such it is interpreted that binding tranexamic acid to a solid support still maintains plasminogen affinity to a degree. Per the same citation it was also found that 1) this tranexamic acid still performed better than other substances tested, and the combination with the resin did not affect the affinity to plasminogen at all. Therefore as Nur teaches that tranexamic acid bound to a solid support is known in the art, still allows binding to plasminogen, and performs better than other substances tested, it would have been obvious to provide the tranexamic acid of the system of Otto and Kroon with a solid support. Said combination would involve some teaching, suggestion, or motivation in the prior art (use of tranexamic acid with a solid support being known to be used in the art and operating better than other combinations tested) that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention and thus a prima facie case of obviousness exists.
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.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781