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 Claims 13-23 and 27-32 are withdrawn from consideration due to a prior restriction request.
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 .
Response to Arguments
Applicant’s arguments, see Applicant Arguments/Remarks Made in an Amendment, filed 5 August 2026, regarding the respective rejections of Claims 1-12 and 24-26 under 35 U.S.C. 102(a)(1) and 103 using Glajch et al. (herein referred to as “Glajch”, US Pat Pub. 4705725) as a primary reference have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103 using Torobin (US 4777154) as a secondary reference. Applicant has amended the claims in a manner that clarifies and narrows the scope of the invention, in particular by requiring a narrower particle size and entirely porous particles. After further consideration, the cited prior art does not disclose this limitation; therefore, the grounds of rejection are withdrawn. New grounds of rejection using Torobin to address the new limitations are made after further search and consideration, and said grounds of rejection are detailed below. Since the arguments do not address these new grounds of rejection, they are now considered moot and will not be further addressed at this time.
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 1, 4-11 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) in view of Torobin, US 4777154.
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 (Col. 13, Example 2; pore size of 300 A); 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).
However, the reference is silent on the particles having a size of about 1.0 μm to about 4.0 μm, although it does describe particles at the size of 5.0 μm (Col. 13, Example 2).
Torobin discloses hollow microspheres made from dispersed particle compositions and their production in the same field of endeavor as the instant application, as it solves the mutual problem of providing silica microspheres to serve as a substrate (Abstract; Col. 2, Lines 58-65; Col. 36, Lines 24-41). Torobin further discloses hollow silica microspheres with a diameter of preferably 0.1 to 10 microns, as particles of this size can link up and form a lattice network to enhance substrate performance (Abstract; Col. 2, Lines 58-65; Col. 19, Lines 30-52; Col. 30, Lines 17-19; Col. 36, Lines 24-41; silica may be used as substrate material; hollow spheres would be entirely porous).
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 particle size of the silica microparticles to be 1.0 to 4.0 microns and to make them entirely porous as taught by Torobin because Torobin discloses microparticles with such a configuration can link up and form a lattice network to enhance substrate performance (Torobin, Abstract; Col. 2, Lines 58-65; Col. 19, Lines 30-52; Col. 30, Lines 17-19; Col. 36, Lines 24-41). See also that since 1.0 to 4.0 microns is about the middle of the range provided by Torobin, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to select that size range.
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 6, Claim 1, upon which Claim 6 is dependent, has been rejected above. The combined references disclose wherein the porous substrate has a particle size of about 3.5 μm, about 2.7 μm or about 1.8 μm (Torobin, Abstract; Col. 2, Lines 58-65; Col. 19, Lines 30-52; Col. 30, Lines 17-19; Col. 36, Lines 24-41; see Claim 1 rejection above, microspheres can be made from 1.0 μm to 4.0 μm).
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 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 Page 7 Application/Control Number: 18/503,722 Art Unit: 1773 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 9, Claim 1, upon which Claim 9 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; 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 catalysts).
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).
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 Page 8 Application/Control Number: 18/503,722 Art Unit: 1773 a column constructed and arranged to hold the separation medium, the column having an inner diameter of about 1.0 to about 100 mm (Col. 12, Example 1; stainless steel tube with 0.46 x 15 cm dimensions, or 4.6 mm).
While Glajch is silent on a length of 35 mm to 70 mm, the reference does disclose a height of 150 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 length of the column to be 35 mm to about 70 mm or length 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 and with expected results; therefore, the claim is not patentably distinct from the teachings of Glajch.
However, the reference is silent on the particles having a size of less than about 2 μm, although it does describe particles at the size of 5.0 μm (Col. 13, Example 2).
Torobin discloses hollow microspheres made from dispersed particle compositions and their production in the same field of endeavor as the instant application, as it solves the mutual problem of providing silica microspheres to serve as a substrate (Abstract; Col. 2, Lines 58-65; Col. 36, Lines 24-41). Torobin further discloses hollow silica microspheres with a diameter of preferably 0.1 to 10 microns, as particles of this size can link up and form a lattice network to enhance substrate performance (Abstract; Col. 2, Lines 58-65; Col. 19, Lines 30-52; Col. 30, Lines 17-19; Col. 36, Lines 24-41; silica may be used as substrate material; hollow spheres would be entirely porous).
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 particle size of the silica microparticles to be less than 2 microns as taught by Torobin because Torobin discloses microparticles with such a configuration can link up and form a lattice network to enhance substrate performance (Torobin, Abstract; Col. 2, Lines 58-65; Col. 19, Lines 30-52; Col. 30, Lines 17-19; Col. 36, Lines 24-41). See also that since less than 2.0 microns covers well over half of the suggested range of Torobin, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to select that size range.
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 Torobin, US 4777154, as applied to claims 1 and 24 respectively above, and further 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 Torobin, US 4777154 as applied to claim 1 above, and further 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Carr et al. (herein referred to as “Carr”, US Pat Pub. 2002/0160196) recites interest in microspheres with a size distribution of mean diameter between 1 and 3 microns in chromatography (Paragraph [0002]), yet this is for nonporous ceramic microspheres instead of porous silica microspheres.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Lebron can be reached at (571) 272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD C GURTOWSKI/ Primary Examiner, Art Unit 1773 09/23/2026
