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.
Claim 28 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
In claim 28, “such that the sorbent bed can be suspended in a fluid” is indefinite as to whether such suspending of a sorbent bed, and by the selected technique which follows is positively recited.
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.
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Claims 21, 22, 26, 28, 29, 32, 35 and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5 of U.S. Patent No. 11,998,862. Although the claims at issue are not identical, they are not patentably distinct from each other because the broader, instant claim limitations are encompassed in the narrower, species claim limitations of patent ‘862.
The limitations of the instant claims are recited in, encompassed in, or obvious from the claims of patent ‘862 as in the following side-by-side comparison:
21. A method of loading affinity ligand on to a support to form an affinity sample preparation device (‘862 paraphrased in the claim 1 preamble and in the “adding” clause concerning “an affinity isolation and purification procedure”, and a device that comprises filter element that blocks passage of affinity sorbent particles, hence provides support for the particles) , the method comprising:
providing the sample preparation device that comprises an internal structure including a reservoir, a well, a fluid passageway, sorbent particles, and a filter element that blocks passage of the sorbent particles, the reservoir having a first volume, a first end and a second end, the first end having a first opening for receiving fluids and the second end having a second opening that opens into the well such that the well and the reservoir are directly adjacent to each other; the well having a second volume, a length, a first end closest to the reservoir, and a second end closest to the fluid passageway, the well having a first internal width at its first end that is greater than a second internal width at its second end; the fluid passageway having a first end closest to the well and a second end comprising an outlet; the filter element positioned at the first end of the fluid passageway; and the sorbent particles forming a sorbent bed within the well, the sorbent bed being positioned adjacent to the filter element and at least partially filling the well; wherein there is no filter element positioned between the reservoir and the well that blocks passage of the sorbent particles (all present throughout the “adding” clause of ‘862, claim 1);
adding a carrier fluid comprising affinity ligands to activate the sorbent particles within the sorbent bed, the affinity ligands comprising imprinted materials and oligosaccharides (‘862, claim 1, “adding clause” concerning the affinity ligands concerning imprinted materials and oligosaccharides, and “adding a sample fluid”);
dispersing the sorbent particles of the sorbent bed in the carrier fluid for a time sufficient for the affinity ligands to bind to the sorbent particles to form affinity sorbent particles (‘862, claim 1, “dispersing” clause); and
removing the carrier fluid from the device through the second end of the fluid passageway, forming a settled bed of affinity sorbent particles (‘862, claim 1, “removing” clause).
22. The method of claim 21, (a) wherein the first opening for receiving fluids is capped, (b) wherein the second end of the fluid passageway is capped, or (c) wherein the first opening for receiving fluids is capped and the second end of the fluid passageway is capped (all encompassed in ‘862, claim 5).
26. The method of claim 21, wherein the first internal width of the well ranges from 2 to 30 times the second internal width of the well (obvious from ‘862, claim 1, “adding” clause concerning the well having a first internal width at a first end which is greater than a second internal width at a second end).
28. The method of claim 21, wherein the well is configured such that the sorbent bed can be suspended in a fluid using a technique selected from shaking on a shaker device, vortex mixing, and aspirating and dispensing using a pipette (paraphrased in ‘862, claim 2 regarding “dispersing being performed by shaking, using a vortex mixer or repeatedly aspirating and dispensing).
29. The method of claim 21, wherein the length of the well ranges from 2 to 20 times the second internal width (obvious from ‘862, claim 1, “adding” clause concerning the well having a length, and a first internal width at a first end which is greater than a second internal width at a second end).
32. The method of claim 21, wherein the affinity ligand is selected from proteins, antibodies, aptamers, affimers, inorganic metal complexes, small organic compounds, hydrophobic molecules, polymer imprinted material, oligonucleotides, and oligosaccharides (‘862, claim 1 “adding” clause concerning “polymer imprinted materials”).
35. The method of claim 21, wherein the dispersing is performed by shaking the device on a shaker device, by using a vortex mixer, or by repeatedly aspirating and dispensing the sample fluid and the affinity sorbent particles (‘862, claim 2 regarding “dispersing being performed by shaking, using a vortex mixer or repeatedly aspirating and dispensing).
36. The method of claim 21, wherein the carrier fluid is removed from the device by centrifugation, by applying a vacuum to the second end of the fluid passageway, by applying a positive pressure to the first opening of the reservoir, or a combination thereof (‘862, claim 3).
Claims 23-25, 27, 30, 31, 33 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5 of U.S. Patent No. 11,998,862 in view of Fisk et al patent 6,723,236 (Fisk). The further limitations of claims 22-25, 27 and 30-34 are not recited in full or in part in the claims of patent ‘862, however are taught in Fisk, and obvious to incorporate in the method described by patent ‘862, in view of Fisk, as in the following side-by-side comparison of claim limitations:
23. The method of claim 21, wherein the well is a tapered well that has a single taper angle, multiple taper angles with discrete transitions therebetween, or a continuous change in taper angle (Such limitation is not present in the claims of ‘862, however, Fisk teaches a bed of sorbent medium in an internally tapered well so as to generate efficient elution of sample compounds in a minimal elution volume at column 4, lines 11-23, and teaches the obviousness of employing multiple tapered angles, of a trapezoidal configurations so as to prevent exiting fluids from creeping up the exterior wall of the device and provide effective beading and dropping of exiting fluids at column 7, lines 4-26 and figures 2 and 5).
24. The method of claim 21, wherein the well is a tapered well that comprises a taper angle that ranges from 10 to 70 degrees relative to a longitudinal axis of the well (Such limitation is not present in the claims of ‘862, however, Fisk teaches a bed of sorbent medium in an internally tapered well so as to generate efficient elution of sample compounds in a minimal elution volume at column 4, lines 11-23, and teaches the obviousness of employing tapered angles of the well , so as to optimize effective filtration area with minimal internal void volume, and prevent exiting fluids from creeping up the exterior wall of the device and provide effective beading and dropping of exiting fluids at column 6, lines 37-46 column 7, lines 4-26 and figures 2 and 5 which clearly show taper angles between 10 and 70 degrees relative to the well longitudinal axis).
25. The method of claim 21, wherein the well has a hollow partial conical shape or a hollow partial pyramidal shape (Such limitation is not present in the claims of ‘862, however, Fisk teaches a bed of sorbent medium in an internally tapered well so as to generate efficient elution of sample compounds in a minimal elution volume at column 4, lines 11-23, and teaches the obviousness of employing an inverted, hollow, partial pyramidal shape of the well , so as to optimize effective filtration area with minimal internal void volume, and prevent exiting fluids from creeping up the exterior wall of the device and provide effective beading and dropping of exiting fluids at column 6, lines 37-46 column 7, lines 4-26 and figures 2 and 5 which clearly show an inverted, hollow, partial pyramidal shape of the well).
27. The method of claim 21, wherein the first internal width of the well ranges from 2 to 30 mm and the second internal width of the well ranges from 1 to 5 mm (Such limitation is not present in the claims of ‘862, however, Fisk teaches a bed of sorbent medium in an internally tapered well so as to generate efficient elution of sample compounds in a minimal elution volume at column 4, lines 11-23, and teaches the obviousness of employing tapered angles of the well, thus generating a larger first width of the well relative to a smaller second width of the well , so as to optimize effective filtration area with minimal internal void volume, and prevent exiting fluids from creeping up the exterior wall of the device and provide effective beading and dropping of exiting fluids at column 4, lines 10-23, column 6, lines 37-46, column 7, lines 4-26 and figures 2 and 5 which clearly show taper angles relative to the well longitudinal axis; additionally, Fisk teaches the above width values at column 4, lines 43-54 which teaches the obviousness of employing such well size so as to minimize the amount of sorbent needed to create a bed length that will be free of adverse imperfections).
30. The method of claim 21, wherein the filter element is selected from a frit and a membrane filter, wherein the filter element is a hydrophobic filter element, or both (Such limitation is not present in the claims of ‘862, however, Fisk teaches a bed of sorbent medium in an internally tapered well so as to generate efficient elution of sample compounds in a minimal elution volume at column 4, lines 11-23, and teaches the obviousness of employing a frit filter at column 6, lines 8-21 so as to retain the sorbent particles).
31. The method of claim 21, wherein the affinity sorbent particles are selected from crosslinked agarose particles, silica-based particles and polymer-based particles (the claims of ‘862 are silent as to type of affinity sorbent particles selected, however, Fisk teaches a bed of sorbent medium in an internally tapered well so as to generate efficient elution of sample compounds in a minimal elution volume at column 4, lines 11-23, and teaches the obviousness of employing polymer-based sorbent particles at column 6, lines 22-33 so as to have the capability of having at least one target or interfering substance adhered to).
33. The method of claim 21, wherein the device comprises a plurality of the internal structures (the claims of ‘862 are silent as to such limitation, however, Fisk teaches a bed of sorbent medium in an internally tapered well so as to generate efficient elution of sample compounds in a minimal elution volume at column 4, lines 11-23, and teaches the obviousness of employing a plurality of sorbent structures at column 6, lines 12-15 regarding “multi-well SPE device” with the inherent motivation to perform affinity separation of larger volumes of sample) .
34. The method of claim 33, wherein the plurality of the internal structures form a multi- well strip, a multi-well plate, or a rack of individual pipette tips (the claims of ‘862 are silent as to such limitation, however, Fisk teaches a bed of sorbent medium in an internally tapered well so as to generate efficient elution of sample compounds in a minimal elution volume at column 4, lines 11-23, and teaches the obviousness of employing a plurality of sorbent structures at column 6, lines 12-15 regarding “multi-well SPE device” with the inherent motivation to perform affinity separation of larger volumes of sample, in a compact, easily transported device).
Allowable Subject Matter
Independent claim 21, and thus also claims 22-36 dependent therefrom, would be allowable if rewritten or amended to overcome the rejections under Obviousness Double Patenting, and for claim 28, also the rejection under 35 U.S.C. 112 (b), set forth in this Office action.
Independent claim 21 would distinguish and be non-obvious over all of the prior art in view of recitation of A method of loading affinity ligand on to a support to form an affinity sample preparation device, the method comprising:
providing the sample preparation device that comprises an internal structure including a reservoir, a well, a fluid passageway, sorbent particles, and a filter element that blocks passage of the sorbent particles, the reservoir having a first volume, a first end and a second end, the first end having a first opening for receiving fluids and the second end having a second opening that opens into the well such that the well and the reservoir are directly adjacent to each other; the well having a second volume, a length, a first end closest to the reservoir, and a second end closest to the fluid passageway, the well having a first internal width at its first end that is greater than a second internal width at its second end; the fluid passageway having a first end closest to the well and a second end comprising an outlet; the filter element positioned at the first end of the fluid passageway; and the sorbent particles forming a sorbent bed within the well, the sorbent bed being positioned adjacent to the filter element and at least partially filling the well; wherein there is no filter element positioned between the reservoir and the well that blocks passage of the sorbent particles;
all of which is cumulatively taught by the closest prior art is represented by Fisk et al patent 6,723,236, Jones patent 7,999,084 and Gjerde (US 20120164750), in view of the further recitation of “adding a carrier fluid comprising affinity ligands to activate the sorbent particles within the sorbent bed, the affinity ligands comprising imprinted materials and oligosaccharides”. Fisk, Jones and Gjerde do not teach or suggest such limitation.
Such teaching of polymer-imprinted oligosaccharide affinity ligands are known in the art from at least Altintas et al and Korpel et al (US 2007/0251885), but it would not have been obvious to have incorporated such types of ligands which are operative to activate sorbent particles comprised in a carrier fluid, as claimed, in methods or devices taught by Fisk, Jones and/or Gjerde so as to arrive at the invention of instant claim 21.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Primary Examiner Joseph Drodge at his direct government formal facsimile phone number telephone number of 571-272-1140. The examiner can normally be reached on Monday-Friday from approximately 8:00 AM to 1:00PM and 2:30 PM to 5:30 PM.
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The telephone number, for official, formal communications, for the examining group where this application is assigned is 571-273-8300.
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JWD
06/27/2026
/JOSEPH W DRODGE/ Primary Examiner, Art Unit 1773
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