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 .
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.
Claim Rejections - 35 USC § 102
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.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent 10,220,332 B2 to Gjerde.
Regarding claim 1, Gjerde discloses a device, including a column, for purifying (i.e., recovering), detecting and using biological cells (i.e., target entities) from a biological sample (see abstract), wherein the sample also comprises contaminants (see Col. 3, lines 25-26), the device comprising:
lower frit 56 (i.e., a first porous unit) having a first set of pores (i.e., first pored member) (see claim 1), wherein the lower end of the column, flanking the first pored member, functions as an inlet and the other side flanking the first pored member functions as a first outlet (see Col. 3, lines 53-57; Figs. 14-18; Col. 7, last paragraph – Col. 8, 1st paragraph; Fig. 3A);
upper frit 50 (i.e., second porous unit), having a second set of pores (i.e., second pored member) (see claim 1) flanked by a second inlet and wherein the upper end of the column, flanking the second pored member, functions as an outlet, the second porous unit 50 positioned downstream of and in fluid communication with the first porous unit 56 (see Col. 3, lines 53-57; Figs. 14-18; Col. 7, last paragraph – Col. 8, 1st paragraph; Fig. 3A);
a chamber between the first porous unit 56 and the second porous unit 50 (see Col. 10, lines 12-15; Figs. 3A-B); and
a plurality of beads 48 comprising capture entities (i.e., a plurality of binding compositions) loadable or loaded in the chamber, each binding composition comprising an antibody or antibody fragment (first moiety) and a second antibody (second moiety) attached to a tagged ligand (see Col. 2, last paragraph – Col. 3, 1st paragraph; Fig. 3A-B; Col. 33, line 22 – Col. 34, line 7);
the plurality of binding compositions bind the tagged ligand to a cell surface marker (i.e., recognition motif) of target entities to form a complexed population of target entities (see Col. 34, lines 4-7; Figs. 4 & 8);
a pore size of the second pored member is impervious to the complexed population of target entities (see Col. 2, lines 39-45; Figs. 3A-B);
the first and second moieties are antibodies (see Col. 33, line 22 – Col. 34, line 7).
Regarding claim 2, Gjerde discloses the invention of claim 1 and discloses wherein a pore size of the first pored member is impervious to large contaminants in the sample (see Col. 3, lines 25-26).
Regarding claim 3, Gjerde discloses the invention of claim 1 and discloses wherein the pore size of the first pored member is impervious to the complexed population of target entities (see Col. 2, lines 39-45; Figs. 3A-B);
Regarding claim 4, Gjerde discloses the invention of claim 1 and discloses wherein, based on time, the amount of target entities exiting the column range from none to 100%, when all the target entities entering the column exit the column (see Fig. 9). At the point where 100% of the target entities are exiting the column, the binding compositions would be considered fully saturated. However, any point prior to that the binding compositions would be below saturation levels and thus reads on the limitation of claim 14.
Regarding claim 5, Gjerde discloses the invention of claim 1 and discloses wherein the moieties of the capture entities of the plurality of binding compositions can interact with the same or different recognition motifs (see Col. 33, line 22 – Col. 34, line 7).
Regarding claim 6, Gjerde discloses the invention of claim 1 and discloses wherein the linker of the plurality of binding compositions connecting the beads to the tagged ligand is comprised of a plurality of antibodies in series (i.e., including third and fourth moieties holding together the first and second moieties) (see Col. 34, lines 4-14).
Regarding claim 7, Gjerde discloses the invention of claim 1 and discloses wherein the first outlet and the second inlet are connectable thereby forming the chamber (see Fig. 3A).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797