DETAILED ACTION
For this Office action, Claims 1-32 are pending. Claims 13-23 and 27-32 are withdrawn from consideration due to a prior restriction requirement.
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 I, Claims 1-12 and 24-26 in the reply filed on 22 April is acknowledged. Claims 1-12 and 24-26 will be examined within this Office action.
Applicant’s request for rejoinder of the nonelected claims is fully considered but denied at this time. Group 2 requires the preparation of both polysorbate 80 and one or more reaction products of polysorbate 80 to read on the claims, wherein the requirement of said one or more reaction products is a limitation not found in Group 1. Furthermore, the lack of such a limitation allows the column of Group 1 to be used for materially different processes, such as characterizing other surfactants beyond polysorbate 80 and reaction products of polysorbate 80. Group 2 would further require more consideration of what could comprise reaction products of polysorbate 80 that would read on the claim, wherein such considerations are not required for Group 1. For these reasons, the rejoinder will not be considered at this time; however, potential rejoinder will be possible later in prosecution if and when the claims of Group 1 are considered allowable and the withdrawn claims comprise all the allowable limitations of Group 1.
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, 4, 5, 7, and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glajch et al. (herein referred to as “Glajch”, US 4705725; found in IDS filed 06/05/2024).
Regarding instant Claim 1, Glajch discloses a chromatography separation column for characterizing surfactant purity (Abstract; Col. 1, Lines 7-23; suitable for affinity chromatography separations, which would include surfactant separations), comprising,
a separation medium comprising a particulate porous substrate having a monofunctional silane with diisopropyl side chain groups and a pendant cyano functional group (Col. 13, Example 2; Example 3; porous silica microspheres as used in Examples 2 and 3 along with 3-cyanopropyldiisopropylchlorosilane), the porous substrate having a pore size of about 50 A to about 500 A and an average particle size of about 1.0 μm to about 100 μm (Col. 13, Example 2; pore size of 300 A, particle size of 5 μm); and
a column constructed and arranged to hold the separation medium, the column having an inner diameter of about 1.0 to about 100 mm and a length from about 10 mm to about 250 mm (Col. 12, Example 1; stainless steel tube with 0.46 x 15 cm dimensions, or 4.6 mm and 150 mm).
Regarding instant Claim 4, Claim 1, upon which Claim 4 has been rejected above. Glajch discloses wherein the porous substrate comprises a hydrated metal oxide (Claim 2, see hydrated metal oxide).
Regarding instant Claim 5, Claim 4, upon which Claim 5 is dependent, has been rejected above. Glajch discloses wherein the porous substrate comprises silica (Col. 13, Example 2; silica microspheres).
Regarding instant Claim 7, Claim 1, upon which Claim 7 is dependent, has been rejected above. Glajch further discloses wherein the porous substrate has a pore size of about 300 A (Col. 13, Example 2, see 300 A).
Regarding instant Claim 9, Claim 1, upon which Claim 9 is dependent, has been rejected above. Glajch further dsiclsoes wherein the porous substrate has a pore size of about 300 A (Col. 13, Example 2; pore size of 300 A).
Regarding instant Claim 10, Claim 1, upon which Claim 10 is dependent, has been rejected above. Glajch further discloses wherein the separation medium can resist degradation over a pH from 1.0 to 8.0 (Col. 2, Line 56-end; Col. 6, Line 61-Col. 7, Line 4; Col. 8, Line 64-Col. 9, Line 13; Col. 11, Line 62-Col. 12, Line 16; see acidic and basic solutions, including pH of 2 and less, also mild basic catalyst along with strongly basic cataysts).
Regarding instant Claim 11, Claim 1, upon which Claim 11 is dependent, has been rejected above. Glajch further discloses wherein the separation column can be used in a temperature range of about 20 to 80⁰C (Col. 4, Lines 14-21; can be used to temperatures of at least 200⁰C).
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.
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.
Claims 6, 8 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Glajch et al. (herein referred to as “Glajch”, US 4705725; found in IDS filed 06/05/2024).
Regarding instant Claim 6, Claim 1, upon which Claim 6 is dependent, has been rejected above. While Glajch only discloses a particle size of 5 μm (Col. 13, Example 2), it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the size to be smaller in order to increase the effective surface area of the particles. Furthermore, the MPEP warns against patentability based on changes in size. See MPEP 2144.04, IV. A., as quoted here. “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. Since the only difference between the instant claim and Glajch is a change in the dimension of the partices, and the change in size would lead to the expected results of increased surface area, the claim is not patentably distinct from Glajch.
Regarding instant Claim 8, Claim 1, upon which Claim 8 is dependent, has been rejected above. While Glajch is silent on an inner diameter of 2.1 mm, the reference does disclose an inner diameter of 4.6 mm (Col. 13, Example 2), it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the size to be 2.1 mm or another dimension that fits the needs of the user. See MPEP 2144.04, IV. A., as quoted here. “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. Since the only difference between the reference and the instant claim is a change in dimension, the prior art device would function similar to that of the instant claim; therefore, the claim is not patentably distinct from the teachings of Glajch.
Regarding instant Claim 24, Glajch discloses a chromatography separation column for the characterization of surfactants (Abstract; Col. 1, Lines 7-23; suitable for affinity chromatography separations, which would include surfactant separations), comprising,
a separation medium comprising a particulate porous substrate having a monofunctional silane with diisopropyl side chain groups and a pendant cyano functional group (Col. 13, Example 2; Example 3; porous silica microspheres as used in Examples 2 and 3 along with 3-cyanopropyldiisopropylchlorosilane), the porous substrate having a pore size of about 300 A and an average particle size of about 5 μm to about 100 μm (Col. 13, Example 2; pore size of 300 A, particle size of 5 μm); and
a column constructed and arranged to hold the separation medium, the column having an inner diameter of about 1.0 to about 100 mm and a length from about 50 mm to about 150 mm (Col. 12, Example 1; stainless steel tube with 0.46 x 15 cm dimensions, or 4.6 mm and 150 mm).
While Glajch only discloses a particle size of 5 μm (Col. 13, Example 2), it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the size to be smaller in order to increase the effective surface area of the particles. Furthermore, the MPEP warns against patentability based on changes in size. See MPEP 2144.04, IV. A., as quoted here. “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. Since the only difference between the instant claim and Glajch is a change in the dimension of the partices, and the change in size would lead to the expected results of increased surface area, the claim is not patentably distinct from Glajch.
While Glajch is silent on an inner diameter of 2.1 mm, the reference does disclose an inner diameter of 4.6 mm (Col. 13, Example 2), it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the size to be 2.1 mm or another dimension that fits the needs of the user. See MPEP 2144.04, IV. A., as quoted here. “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. Since the only difference between the reference and the instant claim is a change in dimension, the prior art device would function similar to that of the instant claim; therefore, the claim is not patentably distinct from the teachings of Glajch.
Claims 2, 3, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Glajch et al. (herein referred to as “Glajch”, US 4705725; found in IDS filed 06/05/2024) in view of Fernandez et al. (herein referred to as “Fernandez”, US Pat Pub. 2010/0137213).
Regarding instant Claims 2 and 3, Claim 1, upon which both claims are dependent, has been rejected above. However, Glajch is silent on the surfactant to be characterized comprising a non-ionic surfactant, wherein the surfactant comprises polysorbate-80.
Fernandez discloses formulations of single domain antigen binding molecules in the same field of endeavor as the instant application, as it solves the mutual problem of providing chromatography separation for surfactants (Paragraph [0032]; Paragraph [0184]; Paragraph [0186]; see chromatography and surfactants). Fernandez further discloses the use of a non-ionic surfactant such as polysorbate-80 in a solution to undergo chromatography in order to form a lypophilized mixture (Paragraph [0012]; Paragraph [0019]; Paragraph [0032]; Paragraph [0184]; Paragraph [0186]; see various concentrations of polysorbate-80 used within the solution).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the surfactant of Glajch to be polysorbate-80 as taught by Fernandez because polysorbate-80 can lypophilize or otherwise alter the surface tension of the liquid undergoing chromatography (Fernandez, Paragraph [0012]; Paragraph [0019]; Paragraph [0032]; Paragraph [0184]; Paragraph [0186]).
Regarding instant Claims 25 and 26, Claim 24, upon which both claims are dependent, has been rejected above. However, Glajch is silent on the surfactant to be characterized comprising a non-ionic surfactant, wherein the surfactant comprises polysorbate-80.
Fernandez discloses formulations of single domain antigen binding molecules in the same field of endeavor as the instant application, as it solves the mutual problem of providing chromatography separation for surfactants (Paragraph [0032]; Paragraph [0184]; Paragraph [0186]; see chromatography and surfactants). Fernandez further discloses the use of a non-ionic surfactant such as polysorbate-80 in a solution to undergo chromatography in order to form a lypophilized mixture (Paragraph [0012]; Paragraph [0019]; Paragraph [0032]; Paragraph [0184]; Paragraph [0186]; see various concentrations of polysorbate-80 used within the solution).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the surfactant of Glajch to be polysorbate-80 as taught by Fernandez because polysorbate-80 can lypophilize or otherwise alter the surface tension of the liquid undergoing chromatography (Fernandez, Paragraph [0012]; Paragraph [0019]; Paragraph [0032]; Paragraph [0184]; Paragraph [0186]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Glajch et al. (herein referred to as “Glajch”, US 4705725; found in IDS filed 06/05/2024) in view of Benkner (US Pat Pub. 2003/0017337).
Regarding instant Claim 12, Claim 1, upon which Claim 12 is dependent, has been rejected above. Glajch is silent on an operating pressure.
Benkner discloses porous fillers coated with polyalkene in the same field of endeavor as the instant application, as it solves the mutual problem of providing chromatography columns (Abstract; Paragraph [0006]). Benkner further discloses that the materials within a chromatography column should be able to resist pressures up to 800 bar in order to withstand the pressures required in the production of a chromatography column (Paragraph [0006]; Paragraph [0028]; Paragraph [0030]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the operating pressure of Glajch to be up to about 400 bar or higher as taught by Benkner because Benkner discloses such pressures are required in the production of the columns themselves (Benkner, Paragraph [0006]; Paragraph [0028]; Paragraph [0030]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD C GURTOWSKI whose telephone number is (571)272-3189. The examiner can normally be reached 9:00 am-5:30pm MT.
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/RICHARD C GURTOWSKI/Primary Examiner, Art Unit 1773 05/29/2026
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