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
The Amendment filed on 30 June 2026 has been entered; claims 1-31 remain pending, of which claims 11-26 were previously withdrawn.
Response to Arguments
Applicant’s arguments, see Page 7 of the Remarks, filed 30 June 2026, with respect to the rejections of claims 1-10 and 27-31 under 35 USC 112(b) have been fully considered and are persuasive. The rejections of claims 1-10 and 27-31 under 35 USC 112(b) have been withdrawn in light of Applicant’s amendments to the claims.
Applicant’s arguments, see Pages 8-9 of the Remarks, filed 30 June 2026, with respect to the rejection(s) of claim(s) 1-10 and 27-31 under 35 USC 103 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 Therefore, the rejection has been withdrawn.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 under 35 USC 103 over JP (‘332) in view of Shende, as necessitated by amendment and as discussed below in detail.
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 1-10 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2014178332A (machine translation provided and relied upon) in view of Shende et al. (Anal. Chem., 2003, 75, 3518-3530), hereinafter “JP (‘332)” and “Shende”.
With respect to claims 1-10, 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.
JP (‘332) does not specifically teach the plurality of porous microspheres are polymeric.
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 JP (‘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). The Examiner submits that the foregoing modification necessarily results in “polymeric” porous microspheres, as required by claim 1.
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) in view of Shende, 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
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 CLARE M PERRIN whose telephone number is (571)270-5952. The examiner can normally be reached 9AM-6PM EST M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CLARE M. PERRIN/
Primary Examiner
Art Unit 1779
/CLARE M PERRIN/Primary Examiner, Art Unit 1779 03 September 2026
Prosecution Insights