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
In response to Applicant’s arguments in the election of Group I with traverse, the Examiner finds Applicant’s remarks persuasive and has withdrawn the previous restriction and rejoined the claims. The current set of claims for examination is Claims 1-20.
Specification
The abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
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 13, 20 and any of their dependent claims 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.
Claim 13 recites the limitations “a second array of projection members” and “a first array of projection members”. It is not clear if these limitations are the same as the original “array of projection members” or not.
Claim 20 recites the limitation “a constituent” on lines 5-6 of the claim. It is not clear if this limitation is a different “constituent” from the original group of “constituents” recited on line 1 of the claim, or if it is part of this original group. Examiner interprets it to be part of the original group.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-11 & 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lally et al., (“Lally”, US 6,090,278), in view of McDonald et al., (“McDonald”, US 4,211,658).
Regarding Claim 1 & 3-11, Lally discloses a chromatographic bed insert, (Columns 12, Sealing Assembllies 18 & 20, See Figures 1A-1D, column 4, lines 3-15), comprising: a base comprising a plurality of openings, (Plate 28 with holes, See column 4, lines 20-30); and an array of projection members positioned on the base, (Upper Sealing Heads 22/Lower Sealing Heads 24 of Columns 12, See Figure 1B, See column 4, lines 4-30), and projecting substantially perpendicular to the base, (See Figure 1B), wherein the chromatographic bed insert has a displacement volume %D which is less than 50% of a volume defined by the chromatographic bed insert, (Columns 12, Assembly 18, Assembly 20 inherently have displacement volume using Media Bed 14 within Columns 12 which is visually less than 50%, See Figures 1A-D, column 4, lines 3-15), and the chromatographic bed insert is configured to reduce a hydraulic radius RH of a chromatography bed comprising the chromatographic bed insert by at least 25% compared to a corresponding chromatography bed which does not comprise the chromatographic bed insert, (Columns 12, Assembly 18, Assembly 20 inherently have displacement volume using Media Bed 14 within Columns 12 which reduces RH by at least 25% compared to a bed without the insert, See Figures 1A-D, column 4, lines 3-15).
Lally does not disclose the chromatographic bed insert is configured to reduce a hydraulic radius RH of a chromatography bed comprising the chromatographic bed insert by at least 25% compared to a corresponding chromatography bed which does not comprise the chromatographic bed insert.
McDonald discloses the chromatographic bed insert is configured to reduce a hydraulic radius RH of a chromatography bed comprising the chromatographic bed insert by at least 25% compared to a corresponding chromatography bed which does not comprise the chromatographic bed insert, (Tubing 10 of column in Figure 5 shrinks in width in comparison to Figure 4, See column 5, lines 42-60, lines 61-66; visually the radius is reduced at least 25%).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the chromatographic bed insert of Lally by incorporating that the chromatographic bed insert is configured to reduce a hydraulic radius RH of a chromatography bed comprising the chromatographic bed insert by at least 25% compared to a corresponding chromatography bed which does not comprise the chromatographic bed insert as in McDonald because “during the shrinkage of the tubing, force is applied to the [bed] material” and “chromatographic cartridges which have been triaxially compressed in this manner have been found to be uniformly and homogenously packed so they exhibit reproducible and uniform separation characteristics”, (See column 4, lines 9-17, McDonald), in which “achieving radial compression… have been greatly simplified”, (See column 3, lines 55-60, McDonald).
Additional Disclosures Included:
Claim 3: The chromatographic bed insert of claim 1, wherein each of the projection members has a projection member height, a first projection member thickness, and a second projection member thickness, and the projection members have a ratio of the first projection member thickness to the second projection member thickness of 1:1 to 20:1, (Upper Sealing Heads 22/Lower Sealing Heads 24 inherently have height/thickness and have ratio of 1:1 since they are uniform in size, See Figure 1A-C, Lally).
Claim 4: The chromatographic bed insert of claim 3, wherein each of the projection members has a ratio of the first projection member thickness to the projection member height of 1:2 to 1:20, (See annotated Figure 1C below, Lally, a thickness of the sealing head 22 is roughly 70 pixels while a length is roughly 550 pixels. This produces a ratio of 1:7.85, anticipating the claimed range at this value).
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Claim 5: The chromatographic bed insert of claim 1, wherein the base comprises a plurality of base members positioned such that the base has the openings, (Plate 28, Plate 26 with holes, Figure 1B, See column 4, lines 18-30, Lally).
Claim 6: The chromatographic bed insert of claim 5, wherein the base members comprise a raised edge oriented in a direction substantially similar to the projection members, (Region defined by location of Clamp 30 of Plates 28/26 are oriented on same level as Sealing Heads 22 or 24, See Figure 1B, Lally).
Claim 7: The chromatographic bed insert of claim 1, wherein the base has the openings that form a pattern which is radially symmetric, (Openings in Plate 28, See Figures 1A/1B, Lally).
Claim 8: The chromatographic bed insert of claim 1, wherein the base has the openings that form a square grid, (Openings in Plate 28 in square pattern, See Figures 1A/1B, Lally).
Claim 9: The chromatographic bed insert of claim 1, wherein the base has the openings that form a hexagonal grid, (Openings in Plate 28 have space for hexagon within square pattern, See Figures 1A/1B, Lally).
Claim 10: The chromatographic bed insert of claim 7, wherein the projection members are positioned on the base such that the array of projection members forms a pattern which is radially symmetric, (Columns 12/Upper and Lower Sealing Heads 22/24 in radially symmetric pattern, See Figure 1B, Lally).
Claim 11: The chromatographic bed insert of claim 8, wherein the projection members are positioned on the base such that the array of projection members forms a square grid, (Columns 12/Upper and Lower Sealing Heads 22/24 in square pattern, See Figure 1B, Lally).
Regarding Claims 15-19, Lally discloses a chromatographic device, (Apparatus, See Figures 1A-D, See column 4, lines 3-10), comprising: a chromatographic medium, (Media Bed 14, See column 4, lines 5-10); and a chromatographic bed insert including a base comprising a plurality of openings, (Plate 28 with holes, See column 4, lines 20-30), and an array of projection members positioned on the base, (Upper Sealing Heads 22/Lower Sealing Heads 24 of Columns 12, See Figure 1B), and projecting substantially perpendicular to the base, (See Figure 1B), wherein the chromatographic bed insert has a displacement volume %D which is less than 50% of a volume defined by the chromatographic bed insert, (Columns 12, Assembly 18, Assembly 20 inherently have displacement volume using Media Bed 14 within Columns 12 which is visually less than 50%, See Figures 1A-D, column 4, lines 3-15).
Lally does not disclose the chromatographic bed insert is configured to reduce a hydraulic radius RH of a chromatography bed comprising the chromatographic bed insert by at least 25% compared to a corresponding chromatography bed which does not comprise the chromatographic bed insert.
McDonald discloses the chromatographic bed insert is configured to reduce a hydraulic radius RH of a chromatography bed comprising the chromatographic bed insert by at least 25% compared to a corresponding chromatography bed which does not comprise the chromatographic bed insert, (Tubing 10 of column in Figure 5 shrinks in width in comparison to Figure 4, See column 5, lines 42-60, lines 61-66; visually the radius is reduced at least 25%).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the chromatographic bed insert of Lally by incorporating that the chromatographic bed insert is configured to reduce a hydraulic radius RH of a chromatography bed comprising the chromatographic bed insert by at least 25% compared to a corresponding chromatography bed which does not comprise the chromatographic bed insert as in McDonald because “during the shrinkage of the tubing, force is applied to the [bed] material” and “chromatographic cartridges which have been triaxially compressed in this manner have been found to be uniformly and homogenously packed so they exhibit reproducible and uniform separation characteristics”, (See column 4, lines 9-17, McDonald), in which “achieving radial compression… have been greatly simplified”, (See column 3, lines 55-60, McDonald).
Additional Disclosures Included:
Claim 16: The chromatographic device of claim 15, wherein the chromatographic device has a corrected hydraulic radius RHC of less than 1 cm, and the corresponding chromatographic device which does not comprise the chromatographic bed insert has RH of at least 1 cm, (See column 6, lines 56-68, column 7, lines 1-13, McDonald; tubing fits retainer of 1 cm in diameter, and shrinks around it to a smaller diameter which is less than 1 cm).
Claim 17: The chromatographic device of claim 15, wherein the chromatographic device has a hydraulic radius RHC of less than 0.75 cm, and the corresponding chromatographic device which does not comprise the chromatographic bed insert has RH of 1 to 5 cm, (See column 6, lines 56-68, column 7, lines 1-13, McDonald; tubing fits retainer of 1 cm in diameter, and shrinks around it to a smaller diameter which is less than 1 cm. Based on annotated figure of Figure 5 below, McDonald, the smaller diameter would be approximately 22 pixels wide compared to the unshrunken (1 cm) 48 pixels wide portion which results in 22/48 x 1 cm = 0.45 cm wide, anticipating claimed range at that value).
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Claim 18: The chromatographic device of claim 15 wherein the chromatographic medium comprises packed particles, (See column 1, lines 15-35, McDonald).
Claim 19: The chromatographic device of claim 18, wherein the particles are at least one selected from the group consisting of a synthetic resin particle, a polysaccharide particle, and an inorganic material particle, (See column 1, lines 15-35, McDonald; silica powder).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lally et al., (“Lally”, US 6,090,278), in view of McDonald et al., (“McDonald”, US 4,211,658), in further view of Baurmeister et al., (“Baurmeister”, US 6,270,674).
Regarding Claim 2, modified Lally discloses the chromatographic bed insert of claim 1, wherein the projection members comprise a fixed end which is connected to the base, (bottom ends of column 12, upper/lower sealing heads 22/24 to plate 28, See Figure 1B).
Modified Lally does not disclose wherein the projection members comprise a free end.
Baurmeister discloses wherein the projection members comprise a free end, (Membranes 2 free on one end, See Figure 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the chromatographic bed insert of modified Lally by incorporating wherein the projection members comprise a free end as in Baurmeister in order to “improve the flow uniformity and increase the pressure”, (See column 5, lines 55-60, Baurmeister).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lally et al., (“Lally”, US 6,090,278), in view of McDonald et al., (“McDonald”, US 4,211,658), in further view of Bio Nanotec Research Institute Inc., (“Machine Translation of JP2004122083A”, “Bio Nanotec”, JP 2004-122083, 21 total pages, published 2004).
Regarding Claims 12-14, modified Lally discloses the chromatographic bed insert of claim 1, but does not disclose it which comprises a plurality of layers each comprising the base and the array of projection members, wherein the layers include a first layer positioned on a second layer and form a stack in which the base of the first layer is positioned on the array of the projection members of the second layer.
Bio Nanotec discloses a chromatographic bed insert which comprises a plurality of layers each comprising the base and the array of projection members, (Layer comprising Plate 2a and Tubular Separation-Membrane Elements 3a and Layer comprising Baffle 5 and Tubular Separation-Membrane Elements 3b, Abstract, Figure 1), wherein the layers include a first layer positioned on a second layer and form a stack in which the base of the first layer is positioned on the array of the projection members of the second layer, (Layer comprising Plate 2a and Tubular Separation-Membrane Elements 3a, See Figure 1). Additional features of this disclosure are included as part of the overall combination and are claim mapped to in the Additional Disclosures section below.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the chromatographic bed insert of modified Lally by incorporating the chromatographic bed insert which comprises a plurality of layers each comprising the base and the array of projection members, wherein the layers include a first layer positioned on a second layer and form a stack in which the base of the first layer is positioned on the array of the projection members of the second layer as in Bio Nanotec so “the processing capacity of this multi-tube separation membrane module is improved”, (See page 3, paragraph 1, Bio Nanotec).
Additional Disclosures Included:
Claim 13: The chromatographic bed insert of claim 12, wherein a second array of projection members, (tubular separation-membrane elements 3a; abstract; figure 1, Bio Nanotec), associated with the second layer, (layer comprising plate 2a and tubular separation-membrane elements 3a; figure 1, Bio Nanotec), is aligned with a first array of projection members associated with the first layer, (tubular separation-membrane elements 3b; layer comprising baffle 5 and tubular separation-membrane elements 3b; abstract; figure 1, Bio Nanotec).
Claim 14: The chromatographic bed insert of claim 12, wherein the first layer, (layer comprising baffle 5 and tubular separation-membrane elements 3b; abstract; figure 1, Bio Nanotec), includes a first base, (baffle 5; figure 1, Bio Nanotec), the second layer, (layer comprising plate 2a and tubular separation-membrane elements 3a; figure 1, Bio Nanotec), includes a second base, (plate 2a; figure 1, Bio Nanotec), and each of the projection members, (tubular separation-membrane elements 3a; figure 1, Bio Nanotec), in the second layer comprises a first end, (right end; figure 1, Bio Nanotec), connected to the first base, (as shown; figure 1, Bio Nanotec), and a second end, (left end; figure 1), connected to the second base, (plate 2a; figure 1, Bio Nanotec).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Natarajan, (US 2009/0321338) in view of Lally et al., (“Lally”, US 6,090,278), in further view of McDonald et al., (“McDonald”, US 4,211,658).
Regarding Claim 20, Natarajan discloses a method of chromatographically separating constituents of a liquid mixture (liquid mixture is separated by the chromatographic apparatus 10; paragraphs [0020], [0031], [0032]), the method comprising: passing the liquid mixture and an eluting solvent through a chromatographic device (raw feedstream, equilibration buffers, wash buffers and elution buffers are passed into the inlet of the apparatus 10; paragraphs [0020], [0031], [0032]); and collecting fractions comprising at least one selected from the group consisting of a constituent of the liquid mixture and the eluting solvent (desired product is obtained at the outlet of the chromatographic apparatus 10 as the first filtrate (constituent of the liquid mixture); paragraphs [0020], [0031], [0032]), wherein the chromatographic device includes a chromatographic medium (packed bed of chromatographic particles 32; paragraph [0022]).
Natarajan does not disclose a chromatographic bed insert including a base comprising a plurality of openings, and an array of projection members positioned on the base and projecting substantially perpendicular to the base, the chromatographic bed insert has a displacement volume %D which is less than 50% of a volume defined by the chromatographic bed insert, and the chromatographic bed insert is configured to reduce a hydraulic radius RH of the chromatographic device by at least 25% compared to a corresponding chromatographic device which does not comprise the chromatographic bed insert.
Lally discloses a chromatographic bed insert including a base, (Columns 12, Assembly 18 & 20, See Figures 1A-1D, column 4, lines 3-15), comprising: a base comprising a plurality of openings, (Plate 28 with holes, See column 4, lines 20-30); and an array of projection members positioned on the base, (Upper Sealing Heads 22/Lower Sealing Heads 24 of Columns 12, See Figure 1B), and projecting substantially perpendicular to the base, (See Figure 1B), wherein the chromatographic bed insert has a displacement volume %D which is less than 50% of a volume defined by the chromatographic bed insert, (Columns 12, Assembly 18, Assembly 20 inherently have displacement volume using Media Bed 14 within Columns 12 which is visually less than 50%, See Figures 1A-D, column 4, lines 3-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Natarajan by incorporating a chromatographic bed insert including a base comprising a plurality of openings, and an array of projection members positioned on the base and projecting substantially perpendicular to the base, the chromatographic bed insert has a displacement volume %D which is less than 50% of a volume defined by the chromatographic bed insert as in Lally so it can “simplify the performance of chromatography analyses with a large throughput volume,” (See column 3, lines 10-16, Lally).
Modified Natarajan does not disclose the chromatographic bed insert is configured to reduce a hydraulic radius RH of a chromatography bed comprising the chromatographic bed insert by at least 25% compared to a corresponding chromatography bed which does not comprise the chromatographic bed insert.
McDonald discloses the chromatographic bed insert is configured to reduce a hydraulic radius RH of a chromatography bed comprising the chromatographic bed insert by at least 25% compared to a corresponding chromatography bed which does not comprise the chromatographic bed insert, (Tubing 10 of column in Figure 5 shrinks in width in comparison to Figure 4, See column 5, lines 42-60, lines 61-66; visually the radius is reduced at least 25%).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the chromatographic bed insert of modified Natarajan by incorporating that the chromatographic bed insert is configured to reduce a hydraulic radius RH of a chromatography bed comprising the chromatographic bed insert by at least 25% compared to a corresponding chromatography bed which does not comprise the chromatographic bed insert as in McDonald because “during the shrinkage of the tubing, force is applied to the [bed] material” and “chromatographic cartridges which have been triaxially compressed in this manner have been found to be uniformly and homogenously packed so they exhibit reproducible and uniform separation characteristics”, (See column 4, lines 9-17, McDonald), in which “achieving radial compression… have been greatly simplified”, (See column 3, lines 55-60, McDonald).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M PEO whose telephone number is (571)272-9891. The examiner can normally be reached M-F, 9AM-5PM.
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779
