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 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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21 of U.S. Patent No. 12,133,716. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are arguably broader than claims 1, 21, of U.S. Patent No. 12,133,716 which encompasses the same metes, bounds and limitations. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was first filed to eliminate the limitations of the narrower claims, since it has been held that omission of an element and its function and a combination where the remaining elements perform the same functions as before involves only routine skill in the art. See in re Karlson, 136 USPQ 184.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 18, of U.S. Patent No. 11,439,310. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are arguably broader than claims 1, 21, of U.S. Patent No. 11,439,310 which encompasses the same metes, bounds and limitations. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was first filed to eliminate the limitations of the narrower claims, since it has been held that omission of an element and its function and a combination where the remaining elements perform the same functions as before involves only routine skill in the art. See in re Karlson, 136 USPQ 184.
Claim Rejections - 35 USC § 103
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy et. Al. (US 2014/0128239) in view of Wanders (US 2016/0109372).
Regarding claim 1, Murphy discloses a method for approximating blood volume in a fluid collected from a subject (page 1, [0004]) comprising: providing a volume of the collected fluid into a container (ensure that a sufficient volume of anticoagulated whole blood remains within the draw bag 530 in page 5, [0054]); determining a volume of sedimented red blood cells in the container from the collected
Fluid (page 1, [0004]; page 6, [0056]); and wherein the volume of sedimented red blood cells correlates with the approximate blood volume in the collected fluid from the subject (page 1, [0003-0004]; page 5, [0054-0056]).
Murphy discloses all the limitations set forth above but fails to explicitly disclose determining a volume of blood in the fluid.
However, Wanders discloses determining a volume of blood in the fluid (determined volume of the blood fluid portion in page 2, [0035]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was first filed to incorporate the features of Wanders within the system of Murphy in order to fill the bowl until the plasma interface reaches a certain position thereby improving the reliability of the system.
Regarding claim 2, Murphy discloses wherein an amount of a red blood cell flocculant is added to the
collected fluid, provided in the container, or both (page 1, [0004]; page 6, [0056]).
Regarding claim 3, Murphy and Wanders disclose all the limitations set forth in claim 1 and Wanders further discloses wherein the red blood cell flocculant is combined with saline (saline solution in page 6, [0077]).
Regarding claim 4, Murphy discloses wherein the red blood cell flocculant comprises polyDADMAC PEI, PAM or a mixture thereof (plasma in page 5, [0054]),
Regarding claims 5-6, Murphy discloses wherein the red blood cell flocculant comprises polyDADMAC (plasma in page 5, [0054])
Regarding claim 7, Murphy discloses solution, a water-in-oil emulsion, or as a dispersion in water (plasma in page 5, [0054]).
Regarding claim 8, Murphy discloses wherein the polyDADMAC comprises a high-molecular weight
polyDADMAC having a molecular weight of about 100 kDa, 200 kDa, 300 kDa, 350 kDa, 400
kDa, 450 kDa, or a combination of the about 100 kDa, 200 kDa, 300 kDa, 350 kDa, 400 kDa and
and 450 kDa polyDADMAC (page 5, [0054]).
Regarding claim 9, Murphy discloses wherein the polyDADMAC has a molecular weight of about 200
kDa, about 350 kDa, or a mixture of the about 200 kDa and about 350 kDa molecular weight
polyDADMAC (page 5, [0054]).
Regarding claim 10, Murphy and Wanders disclose all the limitations set forth in claim 1 and Wanders further discloses wherein the red blood cell flocculant comprises a pre-mixed preparation of the red blood cell flocculant and saline (page 6, [0077]).
Regarding claim 11, Murphy discloses wherein a volume of saline is added to the collected fluid in the
Canister (fig. 6).
Regarding claim 12, Murphy discloses wherein the container is a canister having a volume capacity of
about 1.2 liters, about 3 liters, or about 6 liters (fig. 6).
Regarding claim 13, Murphy discloses wherein the polyDADMAC is provided in an amount of about 320
mg or about 600 mg in a container having a volume capacity of about 1.2 liters (page 5, [0054]).
Regarding claim 14, Murphy discloses wherein the collected fluid from the subject comprises an anti-coagulant (page 5, [0054]).
Regarding claim 15, Murphy discloses wherein the collected fluid from the subject comprises about 40%
blood by volume (page 5, [0054-0056]).
Regarding claim 16, Murphy discloses wherein the collected fluid comprises blood (page 5, [0054]).
Regarding claim 17, Murphy discloses wherein the collected fluid comprises urine, bile, saliva, lymph,
amniotic fluid, peritoneal fluid, or any combination thereof (page 6, [0058]).
Regarding claim 18, Murphy discloses wherein the container comprises a cap or covering (fig. 6).
Regarding claim 19, Murphy discloses wherein the volume of blood in the fluid collected from the subject is a volume in milliliters, Vb, calculated according to the formula: wherein Vb is an estimated blood volume measured in milliliters, Vₘ is an estimated sedimented red blood cell volume measured in milliliters, Hct is an average blood hematocrit, and n is the red blood cell packing ratio of the container (page 5, [0054]).
Regarding claim 20, Murphy discloses where sedimentation of red blood cells from the collected fluid
occurs in about 5 minutes in the container in the presence of the red blood cell flocculant (page 5, [0054-0056]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Felt et al. (US 2007/0203444) discloses apparatus…..components.
James et al. (US 2015/0140546) discloses detecting…..fluid.
Vishnoi et al. (US 2002/0128581) discloses automated…..from blood.
Donart (US 2004/0078022) discloses container….fluid.
Kluck (US 2008/0181828) discloses ultrasound……centrifuge.
Langley et al. (US 2009/0043237) discloses method and devices for processing blood.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL PREVIL whose telephone number is (571)272-2971. The examiner can normally be reached Monday-Friday from 9:30 AM -6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wang Quan-Zhen can be reached at 571 272 3114. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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DP
February 20, 2026
/DANIEL PREVIL/ Primary Examiner, Art Unit 2685
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