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 .
Applicant’s preliminary amendment dated 4 October 2023 is acknowledged. Claims 1-17 and 27-29 as amended are pending.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-8 and 27-29, drawn to a porous size exclusion support and system or kit (characterized as an apparatus) containing it, classified in B01J20/267.
II. Claims 9-14, drawn to method of making a multimodal resin, classified in B01J20/3085.
III. Claims 15-17, drawn to a method of separating molecules, classified in B01D15/36.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the product does not require the method group II, specifically, hydroxyethyl cellulose is not required, and many methods can be used to attach cationic moieties to a support.
Inventions I and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case size exclusion support can be used to separate molecules based on size without cationic association.
Inventions II and III are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed differ because Group I relates to modification of a support, and group II relates to separation of molecules by a support and are mutually exclusive; the method of Group III can be used with different materials than that formed by the process of Group II and thus can have materially different operation, function, and effect. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior art applicable to one invention would not likely be applicable to another invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Francisco Almeida on 11 February 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-8 and 27-29. Affirmation of this election must be made by applicant in replying to this Office action. Claims 9-17 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 1-6, 8, and 27-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2021/050578 A1 (“Ganapathy”).
As to claims 1-6, Ganapathy teaches a size exclusion support (para. 165) that is porous (para. 96). Ganapathy teaches covalently modifying the porous support with polyethyleneimine, which is a cationic moiety as required by claims 1 and 3-6, and the support is made of hydroxyethylcellulose as required by claim 6, and has a cutoff of 40K as required by claim 2. Given the identity of the support, it may be considered a matrix. Since the material is the same as recited is presumed to be capable of separating molecules using the recited characteristics. Moreover, Ganapathy teaches that the moiety interacts by charge interaction (claim 11).
As to claim 8, Ganapathy teaches a spin column, thus a columnar container that spins, and thus is configured for centrifugal force operation, and a tube for collecting flow through, thus a receptacle (para. 178).
As to claim 27, Ganapathy teaches a size exclusion support (para. 165) that is porous (para. 96). Ganapathy teaches covalently modifying the porous support with polyethyleneimine, which is a cationic moiety. Since this is the same material as recited, it is presumed capable of associating with and capturing at least one negatively charged small molecule.
Ganapathy teaches a kit containing the support (para. 153) and instructions (para. 160).
As to claim 28, Ganapathy teaches the kit having a container containing the porous support, a receptacle for flow through (para. 0153).
As to claim 29, the equilibration buffer is optional under claim 28; since Ganapathy teaches a container and receptacle, and thus the limitation is met. However, Ganapathy also teaches the use of buffers in the kit (para. 0155); while not specifying equilibration buffers, Ganapathy teaches the use of the resin in combination with borate (para. 0180).
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.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/050578 A1 (“Ganapathy”) in view of US 2016/0367966 (“Maloisel”).
The discussion of Ganapathy with respect to claim 6 is incorporated by reference. Ganapathy teaches the use of hydroxyethyl cellulose porous supports, but does not discuss crosslinking with epichlorohydrin. Maloisel teaches a similar separation matrix for purification having porous particles that have been amine functionalized (abstract), the porous matrix being of polysaccharide (para. 0050), and teaches the utility of crosslinking the support particles with epichlorohydrin. It would be obvious to modify the supports of Ganapathy using epichlorohydrin, as Maloisel teaches the utility of crosslinking polysaccharide particles for use as chromatography supports.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KREGG T BROOKS whose telephone number is (313)446-4888. The examiner can normally be reached Monday to Friday 9 am to 5:30 pm.
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, Arrie Reuther can be reached at (571)270-7026. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KREGG T BROOKS/Primary Examiner, Art Unit 1764