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 .
Claim Status
Claims 1-31 are pending. Applicant’s election of Group I, Species I in the reply filed on 19 February 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant’s arguments that claims 18-21 should be examined with Species I are not found to be persuasive, as crosslinked polymeric material is still considered to be a distinct species, especially in view of the silica media with polymeric coating without crosslinking as discussed in the art rejections below. Also, if claim 8 is generic, then claim 1 is generic, as claim 8 depends from claim 1. As such, Claims 11-21 are withdrawn.
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 1-10 and 27-31 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.
Regarding claims 1 and 27, “the ambient” lacks antecedent basis in the claim language.
Regarding claims 2-10 and 28-31, they are rejected for being dependent on a rejected base claim.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2014178332A (machine translation provided and relied upon), hereinafter “JP (‘332)”.
With respect to claims 1-7, JP (‘332) teaches ceramic particles for chromatography, wherein the ceramic particles are provided with a plurality of spherical open, continuous (“interconnecting”) pores adjacent to the outer surface, wherein the open pores have an average pore diameter of 500 nm or more (values which are consistent with claims 2-4 which recite dpore for the porous microspheres, and an average diameter of less than 200 microns, as consistent with claims 5-7) (see claims 1-3; also see Page 3, paragraph 5, and Page 2: Paragraphs describing Figs. 1 and 2, paragraph spanning Pages 2-3). As such, the Examiner submits that Inequality (I) recited in claim 1 is satisfied, as n ≥ 2, wherein n is the number of pores on the microsphere outer surface (see Fig. 1, 8).
Regarding the limitation dpore, the Examiner submits that it would have been obvious to the ordinary artisan that the open, continuous pores of the ceramic particles of JP (‘332) meet the limitations pertaining to dpore, the diameter of the porous network, as JP (‘332) teaches that the porosity of the porous body of the microspheres can be controlled by the particle size of the raw material used as the ceramic powder, as well as the firing temperature (Page 4, 4 paragraphs from the bottom). Additionally, JP (‘332) teaches that the open pores communicate throughout the body of the porous microsphere (see paragraph spanning pages 2-3) and average pore size disclosed by JP (‘332) is consistent with dpore as recited in claims 2-4. In view of the foregoing, the Examiner submits that JP (‘332) renders obvious dpore, and the Inequality (I) as recited in claim 1.
Claims 8-10 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2014178332A as applied to claim 1, and further in view of Shende et al. (Anal. Chem., 2003, 75, 3518-3530), hereinafter “JP (‘332)” and “Shende”.
With respect to claims 8-10, JP (‘332) does not specifically teach the recited modified surface groups or hydrophilic layer coating as claimed.
Shende teaches a silica media coated with a (hydrophilic layer) of polyethylene glycol (“non-ionic hydrophilic polymers containing ethylene glycol moieties”).
It would have been obvious to one of ordinary skill in the art to modify the ceramic media of JP (‘332) with the hydrophilic layer comprising polyethylene glycol as taught by Shende because both references disclose a silica media/microsphere used in chromatography (see Abstract of Shende and Page 3, 5th-7th full paragraphs of JAP (‘332)), and because Shende teaches that the polyethylene coating enhanced chromatographic performance, allowing for a high number of theoretical plates as well as excellent run-to-run and column-to-column reproducibility, and pronounced selectivity for a wide range of test solutes (see Abstract).
With respect to claims 27, JP (‘332) does not specifically teach the recited column as claimed; however, all limitations pertaining to the porous microspheres are rendered obvious by JP (‘332), as discussed in detail above for claim 1.
Shende teaches a chromatography column comprising an open hollow tubular body (with each open end of the tube serving as the “at least one inlet” and “at least one outlet”) (see Shende: Page 3, first paragraph of “Column preparation” section).
It would have been obvious to one of ordinary skill in the art to consult the chromatography art to determine an appropriate column with inlets and outlets to use in employing the porous microspheres of JP (‘332) as chromatography filler (see Abstract of JP (‘332).
Claims 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2014178332A in view of Shende et al. (Anal. Chem., 2003, 75, 3518-3530) as applied to claim 27 above, and further in view of Magnussen et al. (U.S. Patent # 4180375) and Kolesinksi et al. (U.S. Patent Publication # 2004/0104156), hereinafter “JP (‘332)”, “Shende”, “Magnussen”, and “Kolesinski”.
With respect to claims 28-30, JP (‘332) is silent with respect to the recited slope of fluid back pressure against fluid flow velocity; however, the Examiner submits that balancing fluid flow and back pressure is well within the skill of the ordinary artisan and is accomplished via conventional means such as pumps and flow meters (see Magnussen, Jr.: Abstract; Column 3, lines 8-17), and see also Kolesinski: Paragraph [0045]).
Additionally, it is submitted that there is no evidence indicating such slopes of plotted fluid flow and back pressure are critical. Where 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 Examiner submits that even the chromatography media is the same as that which is claimed, which the ordinary artisan would recognize would contribute to fluid flow and back pressure as they pertain to media size.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over JP 2014178332A in view of Shende et al. (Anal. Chem., 2003, 75, 3518-3530) as applied to claim 27 above, and further in view of Peyser et al. (U.S. Patent Publication # 2020/0129883), hereinafter “JP (‘332)”, “Shende”, and “Peyser”.
With respect to claim 31, JP (‘332) in view of Shende does not specifically teach close packing as claimed.
Peyser teaches close packing of chromatography stationary phase (Paragraph [0048]).
It would have been obvious to one of ordinary skill in the art to employ close packing as taught by Peyser within the column of JP (‘332) in view of Shende because Peyser teaches that the disclosed separation media exhibits good separation characteristics that are robust to a number of common environmental and usage factors, including transportation, storage, and multiple uses, wherein disclosed columns are characterized by packed beds comprising “interlocked” incompressible particles that are closely packed and resist motion relative to one another, e.g., when subjected to vibration (Paragraph [0048]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLARE M PERRIN whose telephone number is (571)270-5952. The examiner can normally be reached 9AM-6PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bob Ramdhanie can be reached at (571) 270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CLARE M. PERRIN/
Primary Examiner
Art Unit 1779
/CLARE M PERRIN/Primary Examiner, Art Unit 1779 27 March 2026
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