RESPONSE TO AMENDMENT
WITHDRAWN REJECTIONS
The objections to the claims made of record in the office action mailed on 10/01/2025 have been withdrawn due to Applicant’s amendment in the response filed 01/29/2026.
The 35 U.S.C. §112 rejection of the claims made of record in the office action mailed on 10/01/2025 have been withdrawn due to Applicant’s amendment in the response filed 01/29/2026.
REJECTIONS
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103
Claims 1, 9-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wyndham et al (US 2016/0184736 A1) (cited in the IDS filed on 04/15/2025) in view of Chang et al. (WO 2007/038801).
Regarding claims 1, 9 and 11, Wyndham discloses a superficially porous particulate material comprising a substantially non porous core and one or more layers of a porous shell material surrounding the core (par. [0015]), a chromatographic material (par. [0012]). Important factors for the non-spherical cores are that they be relatively uniform in dimensions, free-flowing, non-porous, and mechanically strong enough for use in HPLC and UPLC (par. [0095] meeting limitation “non-porous”). The composition of these cores may be selected from (but is not limited to) silica, metal oxides, diamonds, heavily cross-linked polymers, and hybrid materials (par. [0095], the crosslinked polymers and hybrid materials meeting limitation “organic polymer”). A cross-linked polymer core would have over 95% organic material as claimed. The core material may further be modified by coating with a surface modifier. (par. [0169]-[0178]). Furthermore, the hybrid core may possess or not possess a copolymeric structure (par. [0116]). The invention comprises an inorganic/organic hybrid core (par. [0117]) and the amount of the inorganic portion of the hybrid core ranges from: about 0 molar % to not more than about 1 molar % (par. [0118] meeting limitation “comprising more than 95% organic polymer by composition”).
The shell materials may include hybrid organic-inorganic materials (par. [0110] and [0196]). Prior to forming a shell material, a non-porous hybrid organic-inorganic material surface coating may be applied onto the core. (par. [0096]).
With respect to the transitional phrase “consisting essentially of”, the limitation limits the scope of the claim to specified materials and steps “and those that do not materially effect the basic and novel characteristic(s) of the claimed invention”. MPEP 2113.03 III. For purposes of applying prior art under 35 U.S.C. §102/103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising”. MPEP 2113.03 III. If Applicant contends that additional steps or materials are excluded by the use of “consisting essentially of”, they bear the burden of showing that the introduction of additional steps or components would materially change the characteristics of the claimed invention. The disclosure in Wyndham et al. of a “heavily cross-linked polymer” in par. [0095] would meet the limitation of a core which “consists essentially of organic polymer”. Furthermore, the disclosure of the hybrid material for the core in par. [0095] does not affect the basic and novel characteristics in view of Applicant’s specification. The specification indicates that the “polymer core” is comprises 95% or more organic polymer (Applicant’s spec., par. [0056]), which Wydham et al. satisfies by the disclosure of a hybrid material containing and inorganic portion of the hybrid core ranges from: about 0 molar % to not more than about 1 molar % (par. [0118]) and therefore an organic portion of 99% or more. The specification does not specifically exclude in compounds or teach against any additional materials in the polymer to account for the remaining 5%. As such, the specification therefore does not provide a clear indication of what the basic and novel characteristics actually are, beyond the content of organic material, and is being interpreted as equivalent to “comprising” for purposes of applying prior art.
Wyndham et al. does not explicitly disclose that the non-porous hybrid organic-inorganic surface coating are bonded to the surface of the core using covalent or electrostatic bonds.
Chang et al. discloses core/shell particles comprising organic or inorganic polymeric cores comprising a shell component which may be physically, chemically, ionically or covalently bonded to the core. (par. [0009]). The bonding of the shell disclosed in Chang et al. is described to occur by forming bonds between residues present on the core and moieties in the shell including both covalent and electrostatic interactions (i.e. monomer residues on a core surface as claimed) (par. [0009] and [0081]: describing ester, amide and urethane linkages which require groups present on core and on shell or negatively charged core and positively charged shell).
It would have been obvious to one of ordinary skill in the art to bond the coating materials applied to the modified surface disclosed in Wyndham et al. via one of the bonds disclosed in Chang et al., including electrostatic and covalent bonds.
One of ordinary skill in the art would have found it obvious to bond the shell via method as disclosed in Chang et al. in view of the fact that these are known in the art to be suitable for bonding a shell material to an organic polymer core material. The application of a known process to a product for improving it in the same way in a predictable manner is prima facie obvious. (MPEP 2143 A). Furthermore, the selection of which bonding methods would have allowed on of ordinary skill in the art to select the overall composition of the core and shell material based on what type of polymer material is being used such as whether it would be ionizable or not.
Regarding claims 10 and 12, Wyndham et al. discloses that the surface modifications on the core of the particle may include charged compounds such as amines and amide as well as silane-based compounds. (par. [0309], [0310] and [0341]).
It would have been obvious to one of ordinary skill in the art to bond the shell material to these groups in view of the teachings of Chang et al. regarding the formation of covalent or ionic bonds using functional groups present on the surface of the core material.
Regarding claims 13-14, Wyndham et al. does not explicitly disclose the thickness of the non-porous hybrid organic-inorganic material surface coating.
However, Wyndham et al. discloses that the cores have dimensions of less than 100 nm which is fully encompassed by the presently claimed range (par. [0185]) and that the surface modification may have a controlled thickness to achieve the prevention of side reactions. (par. [0109]). One of ordinary skill in the art would therefore have found it obvious to optimize the overall thickness of the surface modifying coating based on the desired to achieve the improvements resulting from the coating without having an excessively thick coating such that the particle become substantially too large within the disclosure of par. [0185].
Regarding claim 15, Wyndham et al. discloses that the core has a pore volume of less than 0.1 cc/g. (par. [0116]).
Regarding claim 17, Wyndham et al. discloses that the hybrid surface modifier may include silica (i.e. a silicon-based material). (par. [0054]).
Claims 2-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wyndham et al. (U.S. App. Pub. No. 2016/0184736) in view of Chang et al., further in view of Brousmiche et al. (U.S. App. Pub. No. 2019/0322783).
Wyndham et al. and Chang et al. are relied upon as described in the rejection of claim 1, above.
Regarding claims 2-3, Wyndham et al. does not disclose the particular composition of the polymer material for use as the chromatographic material.
Brousmiche et al. discloses a method of making mono-dispersed non-porous polymer particles having a gradient composition for use in chromatography. (Abstract). Brousmiche et al. discloses that the polymer materials include monofunctional, polyfunctional and hydrophilic monomers such as acrylates, methacrylate, styrenes, acrylonitriles, vinyl ester, vinyl halides, vinyl halides, vinyl amides. (par. [0016]-[0019]) all of which are monomers which form a polymer backbone having C-C covalent bonds. Brousmiche et al. further discloses that the particular monomer materials may be selected based on the selection of desired chemical gradient composition, glass transition temperature, degree of crosslinking and properties which may be predetermined by one of ordinary skill in the art. (par. [0057]).
It would have been obvious to one of ordinary skill in the art to use a polymer based on the monomers disclosed in Brousmiche et al. for the polymer core disclosed in Wyndham et al.
One of ordinary skill in the art would have found it obvious to use the polymer materials disclosed in Brousmiche et al. since the secondary reference explicitly discloses them as being suitable for use as a material for chromatography as in the primary reference. The selection of a known material based on its suitability for its intended purpose is prima facie obvious. MPEP 2144.07. Furthermore, one of ordinary skill in the art would have found it obvious to alter the composition of the polymer material based on the desired properties of the particles in a predetermined way as discussed in par. [0057]
Regarding claim 4, Brousmiche et al. discloses that the monomers may have hydrophobic, hydrophilic, polyfunctional and monofunctional monomer residues. (par. [0016]-[0020] and [0023]).
Regarding claim 5, the monomers disclosed in par. [0016]-[0019] of Brousmiche et al. are polymerized by condensation thereof.
Regarding claim 6, an amide as disclosed in Brousmiche et al. is the result of a reaction between a carboxylic acid and an amine.
Regarding claims 7-8, Brousmiche et al. discloses that hydrophilic monomers may include glycidyl methacrylate which is an epoxy containing monomer that is polymerized by ring-opening polymerization. (par. [0019] and [0050]).
ANSWERS TO APPLICANT’S ARGUMENTS
Applicant’s arguments in the response filed 01/29/2026 regarding the prior art rejections made of record in the previous office action have been carefully considered but are deemed unpersuasive.
As discussed in the claim rejections above, the transition phrase “consisting essentially of” does not patentably define over the teachings of Wyndham because a) Wyndham et al. discloses heavily crosslinked polymers and b) the disclosure of a “hybrid material” containing less 1% or less inorganic material does not affect the basic and novel characteristics in view of Applicant’s specification. Therefore, the claims remain unpatentable over the cited prior art.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/ALEXANDRE F FERRE/Primary Examiner, Art Unit 1788 02/17/2026