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
Applicant’s election without traverse of Group I, claims 1-10 in the reply filed on January 22nd, 2026 is acknowledged.
Claims 11-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 22nd, 2026.
Claim Rejections - 35 USC § 102
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 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 Ma (CN 103055773 B, 2016) (the attached machine translation is referenced below).
Regarding claim 1, Ma teaches a chromatographic material comprising a polymer network material-based self-supporting bi-continuous separation matrix comprising a first continuous phase (Ma, [0073], agarose microspheres and a second continuous phase (Ma, [0073], pores of agarose microspheres), wherein the first continuous phase is a portion of the matrix which is formed by a self-gelled polysaccharide (Ma, [0073], agarose) and wherein the second continuous phase is a portion of the matrix which defines non-cylindrical large diameter continuously connected convective pores in-between the first continuous phase (Ma, Figs. 7-9 of the original disclosure show that the pores are not cylindrical; Paragraph [007] of the machine translation discusses convective flow at high flow rates, and Paragraph [0014] states that the agarose microspheres allow higher flow rates), wherein the non-cylindrical large diameter continuously connected convective pores have a median pore diameter of 0.233 μm (Ma, [0073], 233 nm).
Regarding claim 2, Ma teaches the chromatographic material according to claim 1, as discussed above, wherein the self-gelled polysaccharide is agarose (Ma, [0073]).
Regarding claims 3-7, Ma teaches the chromatographic material according to claim 1, as discussed above, but does not explicitly teach a specific median bridge diameter of the first continuous phase relative to the median pore diameter (claim 3), a specific convective porosity (claim 4), a specific permeability (claim 5), a specific coefficient of variance of the median pore diameter (claim 6), or a specific coefficient of variance of a median bridge diameter of the first continuous phase (claim 7). However, it has been held that where claimed and prior art products are produced by identical or substantially similar methods, a prima facie case of anticipation or obviousness has been established. MPEP 2112.01, citing In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). It would not be reasonable to expect different results when performing identical or at least substantially similar steps. Accord, MPEP 2145 II, citing, e.g., In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (stating that “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention”). See also In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (stating the “general rule that merely discovering and claiming a new benefit of an old process cannot render the [old] process again patentable”). In this case, Ma uses the same steps as a particularly preferred embodiment of the instant invention (see instant Specification, Page 23, lines 5-25 and Ma, Paragraph [0073]), so it would not be reasonable to expect Ma’s chromatographic material to have properties different than those claimed.
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 1-2 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over DiLeo (U.S. 2005/0211616 A1).
Regarding claim 1, DiLeo teaches a chromatographic material (DiLeo, [0118]-[0119]) comprising a polymer network material-based self-supporting bi-continuous separation matrix comprising a first continuous phase (DiLeo, Fig. 1, [0118], [0039], agarose is a porous coating PS2) and a second continuous phase (Dileo, [0042], pores formed within coating PS2 which have diffusional flow, implying a continuous phase), the chromatographic material optionally comprising a third inert phase (DiLeo, Fig. 1, [0119], [0039], non-woven fabric FO2463 is a porous substrate PS1), wherein the first continuous phase is a portion of the matrix which is formed by a self-gelled polysaccharide (DiLeo, [0118]) and wherein the second continuous phase is a portion of the matrix which defines large diameter continuously connected convective pores in-between the first continuous phase (DiLeo, [0042]), wherein the large diameter continuously connected convective pores have a median pore diameter of from about 0.001 to 0.2 μm (DiLeo, [0048], claim 10, average pore size of 1 to 200 nm, which would be approximately equal to median pore diameter), which overlaps with the claimed range of 0.1 μm to 6.0 μm, and wherein the third inert phase does not constitute the structure of the second continuous phase (DiLeo, Fig. 1, [0039], [0042], the pores of the porous agarose coating are described separately from the pores of the porous substrate).
It would have been obvious to one of ordinary skill in the art before the
effective filing date of the invention to have selected the overlapping portion of the median pore diameters because selection of overlapping portions of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
DiLeo does not explicitly teach that the large diameter continuously connected convective pores are non-cylindrical. However, there is no reason to expect that the pores formed of DiLeo’s gelation process would spontaneously form into cylinders, and DiLeo does not depict the pore structure in the porous coating as being cylindrical (DiLeo, Fig. 1, [0039] porous coating (PS2) 4).
Regarding claim 2, DiLeo renders the chromatographic material according to claim 1 obvious, as discussed above, wherein the self-gelled polysaccharide is agarose (DiLeo, [0118]).
Regarding claim 8, DiLeo renders the chromatographic material according to claim 1 obvious, as discussed above, further comprising the third inert phase (DiLeo, Fig. 1, [0119], [0039], non-woven fabric FO2463 is a porous substrate PS1).
Regarding claim 9, DiLeo renders the chromatographic material according to claim 1 obvious, as discussed above, but does not explicitly teach that the compressibility of the third inert phase is at least 85%, as determined according to the method indicated in the description. However, DiLeo teaches that the substrate is used for the express purpose of imparting mechanical strength to the adsorptive agarose beads (DiLeo, [0018]), and that, without a mechanically strong substrate, high flow rates cause compression of the beads and flow resistance (DiLeo, [0008]). Such compression at high flow rates corresponds to a lower “compressibility” as claimed and described in the instant Specification, Page 12, line 23 - Page 13, line 1. Thus, DiLeo’s use of a high-“compressibility” substrate allows for the adsorptive layer to function without the additional requirement of the mechanical stability of the adsorptive layer needed to handle flow rates and pressure drops associated with a packed bed of beads (DiLeo, [0109]).
As the flow resistance is a variable that can be modified, among others, by adjusting the compressibility of the third inert phase, with flow resistance both increasing/decreasing as compressibility is increased/decreased, the precise compressibility would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed compressibility cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the compressibility in DiLeo to obtain the desired flow resistance as taught by DiLeo (DiLeo, [0008], [0018], [0109]) (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). A person having ordinary skill in the art would have been apprised of third inert phases having a wide range of compressibilities from among the substrates described in Paragraphs [0053]-[0062] of DiLeo’s disclosure.
Regarding claim 10, DiLeo renders the chromatographic material according to claim 8 obvious, as discussed above, wherein a ratio of a volume of the inert phase to a total volume of the chromatographic material including the third inert phase is about 0.35 (DiLeo, [0119], substrate has a porosity of about 65%).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J. BAUM whose telephone number is (571)270-0895. The examiner can normally be reached Monday-Friday 8:30-5:00.
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/ZACHARY JOHN BAUM/Examiner, Art Unit 1736
/ANTHONY J ZIMMER/Supervisory Patent Examiner, Art Unit 1736