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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-7 and 14, drawn to a silica particle, classified in CPC B01J 20/287.
II. Claims 8-13, drawn to a method for preparing a silica particle, classified in CPC C01B 33/18.
III. Claims 15-17, drawn to a method for purifying a modified conjugated peptide, classified in CPC B01D 15/325.
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 process as claimed can be used to make a materially different product, such as silica-modified carbon nanotubes, and the product as claimed can be made by a materially different process, such as top-down methods of silica nanoparticle generation.
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, the product as claimed can be used in materially different processes, such as a water treatment coagulant or as a binder or filler in ceramics, and the process as claimed can be practiced with a materially different product, such as hydrophobized polystyrene or a hybrid silica-organic phase.
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 can have materially different functions or effects, namely preparation of silica particles (Group II) and the use of silica particles in purification of a modified conjugated peptide (Group III). 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:
Group I would require a search in at least CPC B01J 20/287, along with a unique text search. Group II would not be searched as above and would instead require a search in at least CPC C01B 33/18, along with a unique text search. Group III would not be searched s either of the above and would instead require a search in at least CPC B01D 15/325, along with a unique text search. Separate classification shows that each invention has attained recognition in the art as a separate subject for inventive effort, and also requires a separate field of search. This is sufficient to demonstrate a serious search and/or examination burden. See MPEP 808.02.
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 Michael McKee on 7/8/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-7 and 14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-13 and 15-17 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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because “comprise” and “comprises” are legalese. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The use of the terms Kromasil KR-100-5 SIL, KR-100-10 SIL, KR-200-5 SIL, KR-300-10 SIL, KR-100-10-diC4, KR 10-10-C4, KR-200-5-diC4, 100-5-diC8, 100-5-diC6, and 300-10-diC4, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 1-7 and 14 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.
The term “about” in claims 1, 2, 6, and 7 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Dependent claims 2-7 and 14 are similarly rejected by their dependence on indefinite claim 1.
The term “fine” in claims 1 and 2 is a relative term which renders the claim indefinite. The term “fine” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Dependent claims 2-7 and 14 are similarly rejected by their dependence on indefinite claim 1.
Claims 1 and 2 recite “pore size” as a parameter which characterizes the silica particle, but no measurement method is indicated for this parameter, rendering the scope of the claims indefinite. Dependent claims 2-7 and 14 are similarly rejected by their dependence on indefinite claim 1.
Claims 6 and 7 recite “particle diameter” as a parameter which characterizes the silica particle, but no measurement method is indicated for this parameter, rendering the scope of the claims indefinite.
Claim Rejections - 35 USC § 103
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 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 1-7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Nakajima et al (US 20080249326 A1).
Regarding claims 1 and 14, Nakajima discloses a packing material (stationary phase) for liquid chromatography. While Nakajima does not particularly mention the terminology of reverse-phase HPLC, the liquid chromatography evaluation tests utilize a polar methanol/water mobile phase [0036] paired with the hydrophobically modified silica stationary phase, which is a reverse-phase chromatography setup. Nakajima’s disclosed stationary phase comprises silica compounds which have been chemically modified with a bifunctional silane compound of formula (I), below [0008]:
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In the above formula, R1 represents an alkyl group or an aryl group which can have substituents. R1 may be a straight alkyl group, a branched alkyl group, a cyclic alkyl group or the like [0011]. R1 can have an aryl group, an amino group, a cyano group, or a nitro group at the end thereof, or can have an amide group, a carbamate group, a carbamide group, an ester group, or a carbonate group at a site other than the end thereof [0012]. R1 may be an aryl group which can be a phenyl group, a tolyl group, a mesityl group, a naphthyl group or the like [0011]. X1 and X2 are the same or different and represent a hydrogen atom, a halogen atom or an alkoxy group having 1 to 4 carbon atoms [0008]. Modification with this bifunctional silane compound would result in silica particles analogous to applicant’s formula (I). Nakajima further discloses that the porous silica gel has a fine pore size of 10 to 10000 Å [0010]. A prima facie case of obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05(I).
Regarding claim 2, Nakajima discloses all limitations of claim 1 and further discloses that the porous silica gel has a fine pore size preferably of 50 to 3000 Å [0010]. A prima facie case of obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05(I).
Regarding claim 3, Nakajima discloses all limitations of claim 1 and further discloses two substituents labeled identically as R1, rather than applicant’s disclosure of distinct R1 and R2 groups. Therefore, Nakajima discloses embodiments wherein applicant’s R1 and R2 are the same.
Regarding claims 4 and 5, Nakajima discloses all limitations of claim 1 and further discloses that when R1 is a straight, branched, or cyclic alkyl group, the number of carbon atoms is preferably 1 to 30, and more preferably 2 to 8 [0011]. A prima facie case of obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05(I).
Regarding claims 6 and 7, Nakajima discloses all limitations of claim 1 and further discloses that the porous silica gel has a mean particle size of usually 1 to 1000 µm and preferably 2 to 200 µm [0010]. A prima facie case of obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05(I).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Urano et al (US 20040159611 A1) discloses a chemical modifying agent for preparation of a liquid chromatography packing material which is a modified silane, having three alkyl or aryl substituents and one substituent which is hydrogen, halogen, or alkoxyl having one to four carbon atoms.
Yuita et al (JP 2021512157 A, translation attached) discloses a liquid chromatography method in which hydrocarbon-bonded silica is used as a stationary phase for purification of analogs and derivatives of GLP-1 and GLP-2, such as liraglutide and semaglutide, and describes that the stationary phase is produced from porous silica particles having a chemically bonded hydrocarbon moiety of 4 to 18, preferably 8 to 18, carbon atoms, and the silica particles may have a diameter of 2 to 200 µm, preferably 2.5 to 20 or 5 to 15 µm, and most preferably 10 µm, and may have a pore diameter of 50 to 1000 Å, preferably 80 to 400 or 100 to 300 Å, and most preferably about 100 Å.
Fukuju et al (JP 2012091943 A, translation attached) discloses a hydrophobic aerogel having a particle size of 0.5 to 4 mm and a pore diameter of 18 nm or 22 nm, which is produced by hydrophobizing silica gel with dimethyldichlorosilane.
Ketterer et al (US 20100048883 A1) discloses a method for RNA purification using reverse-phase HPLC with a porous stationary phase having a particle size of 8 to 50 µm having a pore size of 1000 to 5000 Å, which may be a porous silica gel modified with alkyl residues selected from butyl, octyl, or octadecyl containing residues or a porous silica gel modified with phenylic residues.
Törncrona et al (US 9670067 B2) discloses a porous modified silica particle with an average particle diameter of 1.5 to 2.5 µm with branched moieties which are selected from hydrogen, optionally substituted alkyl, alkenyl, alkynyl, aryl, alkylaryl, arylalkyl, heteroalkyl, heterocycle, alkylheterocycle, or heterocyclealkyl, or combinations thereof with a disclosed average pore size of 100 Å.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Savannah G Phillips whose telephone number is (571)270-0822. The examiner can normally be reached M-Th 8-6 ET.
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, Joseph Del Sole can be reached at (571)272-1130. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVANNAH G. PHILLIPS/Examiner, Art Unit 1763
/JOSEPH S DEL SOLE/Supervisory Patent Examiner, Art Unit 1763
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