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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10,792416 in view of US 2003/0125881 to Ryan. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
With regard to instant claims 1 and 8, patented claim 1 recites a method for collecting plasma comprising the steps of determining donor weight and height, donor hematocrit, calculating a donor plasma volume based on donor weight and height hematocrit, calculating a target plasma collection volume based on calculated donor plasma volume and a target percentage of plasma; withdrawing donor whole blood through a venous-access device and lines connected to a blood component separation device; introducing anticoagulant into the withdrawn whole blood through an anticoagulant line; separating whole blood into a plasma component and at least a second blood component; collecting the plasma component from the blood component separation device and into a plasma collection container; calculating a volume of pure plasma collected within the plasma collection container; and continuing those steps until the calculated volume of pure plasma collected within the plasma collection container equals the target plasma collection volume.
Patented claim 1 does not recite that the target percentage of plasma is above 30% of the donor’s plasma volume. However, Ryan discloses that it was known in the art to use a donor specific body weight to calculate and determine the total plasma volume that can be safely taken from a donor (see ¶0005). Ryan’s disclosure teaches that target percentage of plasma is a result-effective variable. That is, the target percentage of plasma will vary with donor characteristics, at least one of which is donor body weight, with the intended result to be a determination of specific blood volume that takes into account patient safety. Accordingly, the recited determination of the particular recited target percentage of plasma volume (i.e., 30%), does not patentably distinguish the claims over the prior art.
With regard to instant claims 2-8, see patented claims 2-8, respectively.
With regard to instant claim 9, see patented claim 1 with the step of calculating a volume of anticoagulant.
With regard to instant claims 10-16, see patented claims 11-17, respectively.
With regard to instant claim 17, patented claim 18 recites a system for collecting plasma comprising: a venous-access device; a blood component separation device, the blood component separation device having an outlet to send the plasma component to a plasma container; a first line fluidly connected to the venous-access device, the flow through the first line being controlled by a first pump; an anticoagulant line connected to an anticoagulant source, a controller configured to control the operation of the blood component separation device and the first pump, the controller configured to calculate (1) a donor plasma volume based on donor weight, height, and hematocrit, (2) a target plasma collection volume based on the calculated donor plasma volume and a target percentage of plasma, (3) a volume of pure plasma collected within the plasma container based upon a the volume of anticoagulant in the collected plasma component, the controller configured to stop the first pump when the calculated volume of pure plasma collected within the plasma container equals the target plasma collection volume.
Patented claim 18 does not recite that the target percentage of plasma is above 30% of the donor’s plasma volume. However, Ryan discloses that it was known in the art to use a donor specific body weight to calculate and determine the total plasma volume that can be safely taken from a donor (see ¶0005). Ryan’s disclosure teaches that target percentage of plasma is a result-effective variable. That is, the target percentage of plasma will vary with donor characteristics, at least one of which is donor body weight, with the intended result to be a determination of specific blood volume that takes into account patient safety. Accordingly, the recited determination of the particular recited target percentage of plasma volume (i.e., 30%), does not patentably distinguish the claims over the prior art.
With regard to instant claims 18-22, see patented claims 19-23, respectively.
With regard to instant claims 23 and 24, see patented claim 26.
With regard to instant claims 25-30, see patented claims 27-32, respectively
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached on Monday-Friday, 9am to 5:30pm.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 22 April 2026
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