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 .
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 01 April 2024.
CLAIMS UNDER EXAMINATION
Claims 37, 45, 63 and 156-165 have been examined on their merits.
PRIORITY
The Applicant claims priority to Provisional Applications 62/276,223, filed on 07 January 2016 and 62/311,373 filed on 21 March 2016. Claim 37 has been amended to recite a therapeutic dosage unit of at least 2.0 x1011 platelets. Provisional Application 62/276,223, provides support for at least about 2.4x1011 platelets (e.g., [0023]). It does not provide support for at least 2.0 x1011 platelets. Support for this limitation is found in 62/311,373 filed on 21 March 2016.
WITHDRAWN REJECTIONS
The previous rejections have been withdrawn due to claim amendment.
NEW REJECTIONS
New rejections have been necessitated by claim amendment.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 37, 45, 63, 156-157 and 160-165 are rejected under 35 U.S.C. 103 as being unpatentable over Shaz et al. (previously cited; Method of Preparing Red Blood Cell and Platelet Products. Patent 9394518 with benefit of Provisional Application 61/417770 filed on 29 November 2010) in view of Fletcher-Haynes et al. (Extracorporeal blood processing information management system. US 2001/0034614 A1) and Triulzi et al. (previously cited; The impact of platelet transfusion characteristics on posttransfusion platelet increments and clinical bleeding in patients with hypoproliferative thrombocytopenia. BLOOD, 7 JUNE 2012 VOLUME 119, NUMBER 23 pages 5553-5562) as evidenced by Pubchem (previously cited; amotosalen).
Shaz discloses a method for preparing a platelet containing product from a plurality of blood units (Abstract). Shaz teaches a recipient (column 2, lines 57-67). Therefore the disclosed product is suitable for administration. The art uses apheresis (see claim 2 of Shaz). The disclosed method can be used for blood banks (column 8, lines 14-16). Shaz teaches the following method (see Abstract; see column 1, lines 55-65):
a) obtaining a plurality of whole blood units,
b) separating a desired cell component from the blood units,
c) leukoreducing the whole blood or the desired cell component;
d) pooling the desired cell components from the blood units,
e) treating the cell component to inactivate one or more pathogens, and
f) adding a storage solution to the cell component. In certain embodiments, the step of inactivating one or more pathogens can take place prior to separating the desired cell component from the pooled blood
As set forth above, the art teaches leukoreduced platelets are produced from multiple blood units prior to pooling. Therefore the platelets from the units are separate prior to pooling. The separated, leukoreduced platelets are interpreted to be an inventory (i.e., a collection) of platelet preparations.
Shaz teaches segregation according to one or more blood type (column 2, lines 36-39; column 3, line 13-16). Therefore Shaz is interpreted to maintain an inventory log of collected platelets and their blood type. The art teaches blood units can be obtained from one donor or a plurality of donors (column 3, line 13-16). Therefore the art has identified an available donor for donating platelets by apheresis.
Claim 37 recites collecting a “new” platelet donation from an available donor. It is noted the specification teaches a “new” donation can be collected at the same time as the donation selected from inventory ([0046]). The specification also discloses embodiments where the new donation can be collected within (before or after) days of the selected donation. Therefore any second donation unit is interpreted to read on a new donation. As state above, Shaz teaches the use of multiple blood units. Shaz teaches any number of blood units can be used to obtain a cell product (i.e., platelets) (column 4, lines 1-2). Therefore the use of two donations is obvious.
Regarding pathogen inactivation: Shaz teaches the product is treated with irradiation to inactive pathogens (column 4, lines 50-51). The irradiation process occurs in the presence of radiation sensitizers including photoactive compounds excited by UV light (column 5, lines 21-35). Therefore the art teaches admixture with a pathogen inactivation compound. The art teaches cells are pooled in a vat and treated via UV radiation (Example 1). The vat is broadly interpreted to be a container of a processing set configured for photochemical pathogen inactivation.
The art teaches dividing the pooled leukoreduced platelets into a plurality of platelet-containing product units, each having a uniform number of platelets (Abstract). The art teaches the platelets are pooled in a container that maintains a sterile environment and allows addition or removal of material without exposure to a non-sterile environment (column 3, lines 60-66). Because the art teaches removal of material without exposure to a non-sterile environment, the art teaches sterile conditions. The pooled product is divided into a plurality of units comprise doses (supra). The use of containers for said uniform doses of platelets would be necessarily present.
The teachings of Shaz are as follows:
Shaz teaches a method of collecting and pooling platelets that can be used at a blood bank. Shaz teaches an inventory (collection) of platelet units collected by apheresis.
Shaz teaches an inventory log comprising blood type. Because Shaz pools individual units by blood type, the art selects a platelet preparation from the inventory for pooling.
Shaz identifies an available donor for donating platelets. Shaz teaches dividing pooled platelets into a plurality of platelet containing product units.
The deficiencies of Shaz are as follows:
The art does not teach maintaining an inventory log with a unique identifier, donation time and a quantity of platelets. The art is silent regarding the number of platelets present in the selected preparation. The art is silent regarding the platelets in the new donation. The art is silent regarding the amount of platelets in the therapeutic dosage units.
Fletcher-Haynes teaches a blood component collection system with data manipulation and optimization capabilities (Abstract; [0011]). The system may contain a detailed log of each donation ([0019]). The following information is collected: donor’s name, donor ID, date of birth and photo ([0124)]; donor blood type ([0127]); procedure time ([0162]) and platelet count post-procedure ([0180]).
The system is able to optimize the process to achieve a predetermined yield of blood components using a manipulation device ([0290]). The system can be configured to provide a number of product-based optimizations such as SPP and DPP. In the United States a single platelet product (SPP) is 3×1011 platelets and a double platelet product (DPP) is 6×1011 platelets ([0290]). In order to increase the probability that the actual yield will equal or exceed the yield requirements for a current U.S. SPP or a DPP, the site may configure a SPP to be 3.5×1011 platelets and a DPP to be 7.0×1011 platelets (e.g., to effectively provide a given confidence level over the minimum that the specified yield will actually be met). See [0290]. Once the optimization is complete, this information may be used in subsequent procedure orders for the particular donor or even for improved efficiency for entire pool of donors ([0292]).
Fletcher-Haynes teaches optimizing the number of platelets collected in a platelet product. The art collects 3.5×1011 platelets. This amount is greater than 2.0x1011 but less than “at least 4.0×1011”. Examiner notes two collections of 3.5 ×1011 platelets (7.0 ×1011 platelets) is a sufficient amount to prepare three therapeutic dosage units of at least 2.0 ×1011 platelets.
Triulzi et al. disclose different dosing strategies for prophylactic platelet transfusions in hematology-oncology patients: lower dose (LD), medium dose (MD), and higher dose (HD) per transfusion (see second paragraph of Introduction on page 5553). “Briefly, adult and pediatric patients undergoing hematologic stem cell transplantation or chemotherapy for hematologic or solid organ malignancy were randomized to 1 of 3 prophylactic platelet dosing strategies, 1.1x1011 (LD), 2.2x1011 (MD), or 4.4x1011 (HD) platelets per square meter of body surface area for each prophylactic platelet transfusion” (see first paragraph of Methods section at right column on page 5553). Therefore the art teaches platelet doses can be low, medium or high.
It would have been obvious to combine the teachings of the prior art by logging a unique identifier, donation time and the quantity of platelets for a donation. Shaz collections platelets from donors and Fletcher-Haynes teach recording a name (a unique identifier), platelet yield (hence, quantity of platelets collected), blood type and donation time for donations. The skilled artisan would collect all of the claimed information since Fletcher-Haynes teach doing so is standard in blood collection. One would have had a reasonable expectation of success since Fletcher-Haynes teach this information can be collected successfully. One would have expected similar results since Shaz and Fletcher-Haynes are both directed to collecting blood components.
It would have been obvious to collect platelet preparations that comprise 3.5×1011 platelets. Shaz teaches an apheresis method for collecting platelets from blood and Fletcher-Haynes teaches an apheresis system that can optimize the number of platelets collected from each donation. Fletcher-Haynes teaches optimizing collection to effectively provide a given confidence level that the specified yield will actually be met. The skilled artisan would select and collect preparations with this amount to increase the yield requirements for a platelet product. One would have had a reasonable expectation of success since Fletcher-Haynes teaches the system allows optimization of each donation. One would have expected similar results since Shaz and Fletcher-Haynes are both directed to platelet collection.
It would have been obvious to prepare three therapeutic dosage units containing at least 2.0 x1011 platelets from the pooled platelets. One would have been motivated to do so since Triulzi teaches a therapeutic dosage can contain 2.2.x1011 platelets. One would do so when preparing a medium dose for a patient. One would have had a reasonable expectation of success since Triulzi Shaz teaches pooled platelets can be divided into therapeutic doses. One would have expected similar results since each reference is directed to preparation of platelet preparations.
Therefore claim 37 is rendered obvious. Therefore claim 37 is rendered obvious.
Claim 45 recites the platelet collection is targeted to yield a donation comprising at least about 125% of the number of platelets required to prepare one therapeutic dosage of platelets, but less than the number of platelets required to prepare two therapeutic dosage units. Examiner notes claim 45 recites the term “about”. The values encompassed by the term “about” are not recited. The Instant Specification does not provide an explicit definition disclosing what values are encompassed by the term about.
Fletcher-Haynes teaches platelet collection can be optimized to yield 3.5×1011 platelets. This is broadly interpreted to be at least about 125% of the number of platelets required for one therapeutic dosage unit, but less than the amount needed for two dosage units. Because the art uses blood for apheresis, this is broadly interpreted to read on providing an input (i.e. blood) to an apheresis system as recited in claim 45. Therefore claim 45 is included in this rejection.
Regarding claims 63: As set forth above, Fletcher-Haynes teaches a single platelet product is a collection of 3x1011 platelets. This amount reads on a therapeutic dosage comprising at least 2.4x1011 platelets. It would have been obvious to optimize the amount of platelets in the preparations. One would have been motivated to do so since fletcher teaches the amount of platelets collected can be optimized based on the desired amount of platelets in the platelet product. In this case, one would increase the amount of platelets to obtain multiple therapeutic doses that contain 3x1011 platelets. Therefore claim 63 is included in this rejection.
Shaz teaches the use of psoralen (column 5, line 26). Therefore claim 156 is included in this rejection.
As evidenced by Pubchem, amotosalen is a psoralen. It would have been obvious to try using amotosalen in the disclosed method. One would have been motivated to do so since Shaz teaches the use of psoralens and amotosalen is a psoralen. KSR B teaches that it is rational to substitute one known, equivalent element for another to obtain predictable results. One would have had a reasonable expectation of success since Shaz teaches psoralens can successfully be used in the disclosed method. Therefore claim 157 is included in this rejection.
Regarding claims 160: As set forth above, Fletcher-Haynes teaches a single platelet product is a collection of 3x1011 platelets. This amount reads on a therapeutic dosage comprising at least 3.0x1011 platelets. It would have been obvious to optimize the amount of platelets in the preparations. One would have been motivated to do so since fletcher teaches the amount of platelets collected can be optimized based on the desired amount of platelets in the platelet product. In this case, one would increase the amount of platelets to obtain multiple therapeutic doses that contain 3x1011 platelets. Therefore claim 160 is included in this rejection.
Regarding claims 161: As set forth above, Fletcher-Haynes teaches a single platelet product is a collection of 3x1011 platelets. This amount reads on a therapeutic dosage comprising at least 2.2x1011 platelets. It would have been obvious to optimize the amount of platelets in the preparations. One would have been motivated to do so since fletcher teaches the amount of platelets collected can be optimized based on the desired amount of platelets in the platelet product. In this case, one would increase the amount of platelets to obtain multiple therapeutic doses that contain 3x1011 platelets. Therefore claim 161 is included in this rejection.
Regarding claims 162: As set forth above, Fletcher-Haynes teaches a single platelet product is a collection of 3x1011 platelets. This amount reads on a therapeutic dosage comprising at least 2.5x1011 platelets. It would have been obvious to optimize the amount of platelets in the preparations. One would have been motivated to do so since fletcher teaches the amount of platelets collected can be optimized based on the desired amount of platelets in the platelet product. In this case, one would increase the amount of platelets to obtain multiple therapeutic doses that contain 3x1011 platelets. Therefore claim 162 is included in this rejection.
Regarding claims 163: As set forth above, Fletcher-Haynes teaches a single platelet product is a collection of 3x1011 platelets. This amount reads on a therapeutic dosage comprising at least 2.6x1011 platelets. This amount reads on a therapeutic dosage comprising at least 2.5x1011 platelets. It would have been obvious to optimize the amount of platelets in the preparations. One would have been motivated to do so since fletcher teaches the amount of platelets collected can be optimized based on the desired amount of platelets in the platelet product. In this case, one would increase the amount of platelets to obtain multiple therapeutic doses that contain 3x1011 platelets. Therefore claim 163 is included in this rejection.
As set forth above, Shaz teaches pathogen activation of the pooled product (see figure 1). Therefore claim 164 is included in this rejection.
As set forth above, Shaz teaches pathogen activation of the pooled units. While the art does not explicitly teach pathogen inactivation of individual units, it would have been obvious to do so. The MPEP teaches selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. See MPEP 2144.04
C. Changes in Sequence of Adding Ingredients. Therefore claim 165 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claims 158-159 are rejected under 35 U.S.C. 103 as being unpatentable over Shaz et al. in view of Fletcher-Haynes and Triulzi as applied to claim 37 above, and further in view of Gernsheimer et al. (previously cited; Blood Component Therapy 2012, pages 1-12).
Claim 37 is rejected on the grounds set forth above. Shaz teaches platelets may be collected from more than one donor. The art teaches platelets can be obtained by apheresis. Shaz teaches pooling platelets that have been collected.
The art is silent regarding the time between the collection of platelets from donations.
Gernsheimer teaches apheresis platelet units are collected from a single donor and are equivalent to a pooled platelet unit containing ~4-6 pooled units; an apheresis platelet unit contains 200-400mL of plasma. They may be collected and given as a random unit (random apheresis platelets) or collected for a specific recipient from an HLA-compatible donor (matched apheresis platelets). Apheresis platelets expire 4 hours after processing for release from the blood center unless incubated storage is used at the local hospital. See first paragraph of page 5.
It would have been obvious to collect platelets from two donors within 24 hours of each other. Because apheresis platelets expire 4 hours after processing, one would have been motivated to collect a second sample within 4 hours of a first collection to allow pooling before the platelets expire. One would have had a reasonable expectation of success since Gernsheimer indicates platelets within 4 hours of processing are viable. One would have expected similar results since Shaz and Gernsheimer are both directed to apheresis platelets. Because 4 hours reads on “within 24 hours”, claim 158 is included in this rejection. Because 4 hours reads on “within 12 hours”, claim 159 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
RESPONSE TO APPLICANT’S ARGUMENTS
The arguments made in the response filed on 28 July 2025 are acknowledged.
The Applicant states the references fail to teach a step of selecting from an inventory log at least one platelet preparation for combining with a new platelet donation. The Applicant argues Shaz merely discloses pooling units of platelets into a vat, then removing sufficient cells for single doses. The Arguments state it would be impossible to select a platelet preparation from an inventory because the platelets are not maintained as individual preparations. The Applicant states the purpose of Shaz is to provide a uniform product across individual units.
In response: Shaz teaches (see Abstract; see column 1, lines 55-65):
a) obtaining a plurality of whole blood units,
b) separating a desired cell component from the blood units,
c) leukoreducing the whole blood or the desired cell component;
d) pooling the desired cell components from the blood units,
e) treating the cell component to inactivate one or more pathogens, and
f) adding a storage solution to the cell component. In certain embodiments, the step of inactivating one or more pathogens can take place prior to separating the desired cell component from the pooled blood
Shaz teaches separation by apheresis. Examiner notes the desired cell components (i.e., platelets) are separated from a plurality of units prior to pooling. Therefore Shaz teaches an inventory (i.e., a collection) of individual preparations of platelets. Shaz teaches individual units are pooled following separation of the desired component (i.e., the platelets) and leukoreduction. After pooling, the art teaches dividing into uniform doses. While the Applicant appears to argue Shaz is insufficient because it teaches uniform doses, claim 37 requires preparation of uniform doses: three units that each comprises at least 2.0x1011 platelets.
The deficiency of Shaz is the reference is silent regarding the number of platelets present in the selected platelet preparation and the “new” platelet preparation. Fletcher-Haynes is relied upon because it teaches a system for optimizing the number of platelets collected. Fletcher-Haynes teaches a system used to collect 3.5x1011 platelets by apheresis.
The Applicant argues Fletcher-Haynes does not teach or suggest combining and separating said apheresis donations into therapeutic dosage units.
In response: Fletcher-Haynes is not relied upon to teach to teach pooling or separation into therapeutic dosage units. Shaz teaches pooling platelets collected by apheresis, and dividing into therapeutic dosage units. Therefore this argument is not persuasive.
of doses
The Applicant argues Shaz fails to disclose subjecting the pooled platelet preparation in admixture with the PIC to a pathogen inactivation process comprising subjecting the pooled platelet preparation in admixture with the PIC to photochemical pathogen inactivation in a container of a processing set configured for photochemical pathogen inactivation, as recited in the amended claims.
In response: As set forth above, Shaz teaches d) pooling the desired cell components from the blood units and e) treating the cell component to inactivate one or more pathogens. Claim 37 encompasses any pathogen inactivation compound. Shaz teaches irradiation and treatment with a compounds that read on the claim (supra). Therefore the argument is not persuasive.
CONCLUSION
No Claims Are Allowed
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653