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 .
Election/Restrictions
Applicant’s election without traverse of Group II, Claims 19-34, in the reply filed on 03/23/2026 is acknowledged.
Claims 1-18 and 35-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/23/2026.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 19-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DiCesare et al. (USP 6,516,953 B1).
Regarding claim 19, DiCesare discloses a float retention assembly (Fig. 5, Fig. 8), comprising:
a container defining a lumen (see: volume defined by tube 12);
a float inserted within a bottom of the container (see: seal plug assembly 64); and
a volume of fluid sufficient to cover the float positioned at the bottom of the container such that a vapor lock between the float and the container is formed and a position of the float is secured relative to the lumen of the container (see: blood 96).
Regarding claim 20, DiCesare further discloses the float is inserted within the bottom of the container such that a majority of air from below the float is displaced to above the float (Fig. 5, see: seal plug assembly 64 is fully submerged in the blood 96).
Regarding claim 21, DiCesare further discloses the float further comprises a float channel defined through or along a side of the float from a lower float portion to an upper float portion (Fig. 8, see: central passage 74).
Regarding claim 22, DiCesare further discloses the float comprises a compressible float collar positioned about the float (Fig. 8, see: annular sealing flanges 76, 78).
Regarding claim 23, DiCesare further discloses the float comprises a first float stem portion having an upper float end located on a proximal end of the first float stem portion (Fig. 8, see: elastomeric septum 68), and a second float stem portion having a lower float end located on a distal end of the second float stem portion (Fig. 8, see: shell 66).
Regarding claim 24, DiCesare further discloses the float further comprises a float channel extending through the first float stem portion and the second float stem portion (Fig. 8, see: central passage 74).
Regarding claim 25, DiCesare further discloses the float comprises an upper float end (Fig. 8, see: elastomeric septum 68) and a lower float end (Fig. 8, see: shell 66).
Regarding claim 26, DiCesare further discloses the upper float end defines a concave surface (Fig. 8, see: conical top wall 90 of septum 68 deflected into a concave configuration).
Regarding claim 27, DiCesare further discloses the upper float end defines a first angled surface having a first slope relative to a longitudinal axis of the float (Fig. 8, see: slope of conical top wall 90 of septum 68 deflected into a concave configuration).
Regarding claim 28, DiCesare further discloses the first angled surface is defined over an entirety of the upper float end such that the float defines a minimum height in proximity to a channel defined through or along the float and extending from the upper float end to the lower float end (Fig. 8, see: slope of conical top wall 90 of septum 68 deflected into a concave configuration).
Regarding claim 29, DiCesare further discloses the upper float end further defines a second angled surface having a second slope which is different from the first slope over a portion of the upper float end (Fig. 8, see: slope of the peripheral rim of septum 68, opposite of conical top wall 90 deflected into a concave configuration).
Regarding claim 30, DiCesare further discloses the lower float end defines a concave surface (Fig. 8, see: concave rim of central passage 74 disposed on the bottom surface of the shell 66).
Regarding claim 31, DiCesare further discloses a septum which seals the lumen to maintain a negative pressure within the container (Fig. 5, see: tube closure 34).
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.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over DiCesare et al. (USP 6,516,953 B1), in view of Van Vlasselaer (USP 5,840,502).
Regarding claim 32, DiCesare does not explicitly disclose the volume of fluid comprises saline within the bottom of the container.
Van Vlasselaer teaches an analogous device and method for enriching cell-types by density gradient centrifugation using phosphate buffered saline to separate fetal nucleated red blood cells in a blood sample (C20/L10-29). It would have been obvious to one having ordinary skill in the art to incorporate saline into the device disclosed by DiCesare, as taught by Van Vlasselaer since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over DiCesare et al. (USP 6,516,953 B1), in view of Dorian et al. (US 2020/0009551 A1).
Regarding claims 33-34, DiCesare does not explicitly disclose the volume of fluid comprises ACD-A anticoagulant within the bottom of the container.
Dorian teaches an analogous apparatus and method for separating blood components comprising a rube filled with agents such as a volume of anticoagulant ACD-A ([0069]; [0149]). It would have been obvious to one having ordinary skill in the art to incorporate ACD-A into the device disclosed by DiCesare, as taught by Dorian, in order to enable blood to be drawn directly into the tube without the need for additional processing (Dorian: [0020]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Leach et al. (US 2008/0283474 A1) discloses an analogous buoy suspension fractionation system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J EOM whose telephone number is (571)270-7075. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM).
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/ROBERT J EOM/ Primary Examiner, Art Unit 1797
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