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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. With regard to claims 8 and 18, Applicant’s claim sets forth a control system in electronic communication with the controller wherein the control system does the calculating the target volume of plasma to be collected and the controller is programmed to determine a target value of plasma product by receiving the target value from the control system. The claim is redundant and fails to specifically point out the metes and bounds of the invention.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 16-17, 19-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 3, 1/9, 3, 19, 12/15/21,15, 24, 25 of U.S. Patent No. 12,186,474 to Ragusa. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
With regard to claims 1, 2, 5, 16, see ‘474 patented claim 1. Patented claim 1 recites a system with a venipuncture needle, a blood separator with a plasma output port connected to a plasma line and plasma collection container, a donor line coupled to the venipuncture needle to carry blood from the donor to the blood separator via a first pump, and an anticoagulant line coupled to an anticoagulant source and a second pump wherein the anticoagulant line supplies anticoagulant to the whole blood collected from the donor. The apparatus further comprises a user interface that can receive input related to patient weight and hematocrit to determine a patient total blood volume and a target volume of plasma product to be collected, and a controller to operate draw and return cycles to draw whole blood, separate it, and return a second component to the donor, wherein the controller adjusts the draw and return cycles based on changing hematocrit.
With regard to instant claims 3, 4, 7, see ’474 patented claims 2, 5, 3. respectively.
With regard to claims 16, 17, 19, 20, 21, 22, 23 see ’474 patented claims 1/9, 3, 19, 12/15/21,15, 24, 25 respectively.
Claims 9-15, 24-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 3, 1/9, 3, 19, 12/15/21,15, 24, 25 of U.S. Patent No. 12,186,474 to Ragusa in view of US Patent No. 10,792,416 to Ragusa. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
In the claims, Ragusa ’474 sets forth the invention substantially as claimed in the instant application. With regard to claims 9-11 and 24-26, the ’416 patent sets forth the use of an anticoagulant weight sensor configured to measure anticoagulant weight and calculate change in anticoagulant volume within the anticoagulant source as well as the collected plasma in order to precisely determine when the target volume of plasma has been collected (see ’416 claim 25). It would have been obvious to a person having ordinary skill in the art at the time of filing to use a weighing means for assessing the anticoagulant use as disclosed by Ragusa ’416 in the apparatus claimed by Ragusa ’474, in order to accurately assess plasma product collection.
With regard to claims 12-14 and 27-29, Ragusa ’474 sets forth the invention substantially as claimed in the instant application. The ’416 patent sets forth the use pump rotations to calculate the consumption of anticoagulant in order to precisely determine when the target volume of plasma has been collected (see ’416 claim 26). It would have been obvious to a person having ordinary skill in the art at the time of filing to use a rotation counter for assessing the anticoagulant use as disclosed by Ragusa ’416 in the apparatus claimed by Ragusa ’474, in order to accurately assess plasma product collection.
With regard to claims 15 and 30, Ragusa ’474 sets forth the invention substantially as claimed in the instant application. The ’416 patent sets forth the use of a plasma product collection weight sensor in order to precisely determine when the target volume of plasma has been collected (see ’416 claims 28, 29). It would have been obvious to a person having ordinary skill in the art at the time of filing to use a plasma product collection weight sensor as disclosed by Ragusa ’416 in the apparatus claimed by Ragusa ’474, in order to accurately assess plasma product collection.
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 Monday-Friday, 9am to 5:30pm.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 18 November 2025