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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2025 has been entered.
Claim Interpretation
The Examiner notes that “biological molecules or biological ions” are interpreted as any molecules or ions that can be produced biologically.
The Examiner notes that the term “membrane” is interpreted as encompassing any semi-permeable structure, according to the general definition of the term, absent a special definition of the term provided in the specification.
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) 1-2, 4-8, 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Iwanaga et al (US 20190100630A1), hereinafter ‘Iwanaga’, in view of US6670402B1, hereinafter ‘Lee’.
Regarding Claim 1, Iwanaga discloses a method of critical point drying a composite material ([0030], [0170]), comprising the steps of
providing a composite material ([0030]) comprising:
a support member, comprising a plurality of pores extending through the support member ([0175], [0180]: a porous support member is provided with the aerogel composite); and
a macroporous cross-linked gel, wherein the macroporous cross-linked gel comprises a polymer formed from a reaction of one or more polymerizable monomers with one or more cross-linkers ([0146]-[0149]: a wet gel is formed by the addition of a base catalyst to a sol solution – by this process, gelation occurs, in which silane monomers are cross-linked and polymerize by the addition of the base catalyst, which is considered a cross-linker. By the polymerization of said silane monomers, a macroporous cross-linked gel is formed; [0074]: the average pore diameter is preferably between 25 and 500 nm – the majority of this range is in the macropore range, and therefore this gel is considered to read upon a macroporous gel);
the macroporous cross-linked gel is located in the pores of the support member ([0181]: the gel is impregnated into the support member, and gelled therein – this would result in gel formed within the pores of the support); and
said macropores of the macroporous cross-linked gel are smaller than the pores of the support member (given that the gel is formed within the pores of the porous support, the pores of the gel within said pores must necessarily be smaller than the pores they occupy in the support);
contacting the composite material with a supercritical fluid at a temperature and a pressure above the critical point of the supercritical fluid, wherein the gaseous and liquid phases are indistinguishable ([0172]: the gel is dried by supercritical drying, wherein the solvent contained in the wet gel is removed by contacting the wet gel with the supercritical fluid at a temperature and pressure equal to or higher than the critical point of the solvent; further, every supercritical fluid is defined as a fluid wherein the gaseous and liquid phases are indistinguishable).
Further regarding Claim 1, while Iwanaga discloses controlling evaporation by maintaining the temperature, thereby critical point drying the composite material ([0171]-[0172]: supercritical drying is performed at a temperature, implying that the chosen drying temperature is maintained for the duration of drying – this is also evidenced by Example 1, where drying occurs at 60 °C and is not disclosed as being adjusted), Iwanaga does not disclose that the pressure is reduced to control evaporation.
Lee discloses methods of more rapidly producing an aerogel product by means of solvent exchange of solvent inside wet gels with supercritical CO2 (Abstract). A person of ordinary skill in the art would have recognized Lee as analogous to Iwanaga, as both references are drawn to the same field of endeavor as the claimed invention, supercritical aerogel drying techniques - a reference is analogous art to the claimed invention if the reference is from the same field of endeavor as the claimed invention, In re Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212.
Further, Lee discloses that once the solvent has been exchanged for supercritical fluid throughout the entire volume of the aerogel, the next step to complete the preparation of the aerogel is to release the pressure in the extractor so that the aerogel can be returned to atmospheric pressure - if the pressure is simply released in an uncontrolled manner, the supercritical fluid will return to a liquid state damaging the aerogels. Lee discloses that supercritical CO2 will tend to cool as it expands unless sufficient heat is supplied to the interior of the gels to prevent the supercritical CO2 from turning into liquid CO2 that will damage the aerogels that have been prepared, and therefore teaches depressurizing the extractor slowly while maintaining the temperature in the reactor above the critical temperature (Col 14, lines 20-42).
Accordingly, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to decrease the pressure while maintaining the temperature in the drying process of Iwanaga, as doing so would prevent damage to the aerogels, thereby preserving the structural integrity thereof.
Regarding Claim 2, Iwanaga discloses a method of critical point drying a composite material ([0030], [0170]), comprising the steps of
providing a composite material ([0030]) comprising:
a support member, comprising a plurality of pores extending through the support member ([0175], [0180]: a porous support member is provided with the aerogel composite); and
a macroporous cross-linked gel, wherein the macroporous cross-linked gel comprises a polymer formed from a reaction of one or more polymerizable monomers with one or more cross-linkers ([0146]-[0149]: a wet gel is formed by the addition of a base catalyst to a sol solution – by this process, gelation occurs, in which silane monomers are cross-linked and polymerize by the addition of the base catalyst, which is considered a cross-linker. By the polymerization of said silane monomers, a macroporous cross-linked gel is formed; [0074]: the average pore diameter is preferably between 25 and 500 nm – the majority of this range is in the macropore range, and therefore this gel is considered to read upon a macroporous gel);
the macroporous cross-linked gel is located in the pores of the support member ([0181]: the gel is impregnated into the support member, and gelled therein – this would result in gel formed within the pores of the support); and
said macropores of the macroporous cross-linked gel are smaller than the pores of the support member (given that the gel is formed within the pores of the porous support, the pores of the gel within said pores must necessarily be smaller than the pores they occupy in the support); wherein
the composite material is wetted with an aqueous solution ([0128]: the gel obtained is a wet gel, and therefore the gel is wetted with an aqueous solution);
exchanging the aqueous solution with a polar organic solvent, such that the composite material is wetted with the polar organic solvent ([0163]-[0164]: the liquid in the wet gel is exchanged with a polar organic solvent, such as methanol or ethanol);
contacting the composite material with a supercritical fluid at a temperature and a pressure above the critical point of the supercritical fluid, wherein the gaseous and liquid phases are indistinguishable ([0172]: the gel is dried by supercritical drying, wherein the solvent contained in the wet gel is removed by contacting the wet gel with the supercritical fluid at a temperature and pressure equal to or higher than the critical point of the solvent; further, every supercritical fluid is defined as a fluid wherein the gaseous and liquid phases are indistinguishable); and
the polar organic solvent is miscible with the supercritical fluid ([0172]: the use of supercritical CO2 is disclosed for supercritical drying – the polar organic solvents utilized by Iwanaga, such as methanol or ethanol, are known to be miscible in supercritical CO2); and
Further regarding Claim 2, while Iwanaga discloses controlling evaporation by maintaining the temperature, thereby critical point drying the composite material ([0171]-[0172]: supercritical drying is performed at a temperature, implying that the chosen drying temperature is maintained for the duration of drying – this is also evidenced by Example 1, where drying occurs at 60 °C and is not disclosed as being adjusted), Iwanaga does not disclose that the pressure is reduced to control evaporation.
Lee discloses methods of more rapidly producing an aerogel product by means of solvent exchange of solvent inside wet gels with supercritical CO2 (Abstract). A person of ordinary skill in the art would have recognized Lee as analogous to Iwanaga, as both references are drawn to the same field of endeavor as the claimed invention, supercritical aerogel drying techniques - a reference is analogous art to the claimed invention if the reference is from the same field of endeavor as the claimed invention, In re Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212.
Further, Lee discloses that once the solvent has been exchanged for supercritical fluid throughout the entire volume of the aerogel, the next step to complete the preparation of the aerogel is to release the pressure in the extractor so that the aerogel can be returned to atmospheric pressure - if the pressure is simply released in an uncontrolled manner, the supercritical fluid will return to a liquid state damaging the aerogels. Lee discloses that supercritical CO2 will tend to cool as it expands unless sufficient heat is supplied to the interior of the gels to prevent the supercritical CO2 from turning into liquid CO2 that will damage the aerogels that have been prepared, and therefore teaches depressurizing the extractor slowly while maintaining the temperature in the reactor above the critical temperature (Col 14, lines 20-42).
Accordingly, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to decrease the pressure while maintaining the temperature in the drying process of Iwanaga, as doing so would prevent damage to the aerogels, thereby preserving the structural integrity thereof.
Regarding Claims 4-6, the prior art meets the limitations of Claim 1 as shown above. Further, Iwanaga discloses the use of carbon dioxide in supercritical drying ([0172]).
Regarding Claim 7, the prior art meets the limitations of Claim 1 as shown above. Further, Iwanaga discloses adjusting the temperature during contact with the supercritical fluid ([0172]: a temperature for supercritical drying is disclosed – maintaining this disclosed temperature is considered “adjusting” the temperature during contact with the supercritical fluid).
Regarding Claim 8, the prior art meets the limitations of Claim 7 as shown above. Further, Iwanaga discloses the use of methanol and ethanol as polar organic solvents as discussed above.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as shown above. Further, Iwanaga discloses the use of a support comprising PET, or polyethylene terephthalate ([0193]) – this is considered a polyester, as it is a member of the polyester family.
Regarding Claim 12, the prior art meets the limitations of Claim 1 as shown above. Further, Iwanaga discloses a film member provided with aerogel ([0192]) – this aerogel film is considered a membrane.
Regarding Claim 13, the prior art meets the limitations of Claim 1 as shown above. Further, Iwanaga discloses a film member provided with aerogel ([0192]) – this aerogel film is a membrane, and the film member is an interleaf layer.
Regarding Claim 14, the prior art meets the limitations of Claim 13 as shown above. Further, Iwanaga discloses the use of a PET film to support an aerogel layer ([0192]) – this PET film is a polyethylene interleaf layer.
Regarding Claim 15, the prior art meets the limitations of Claim 1 as shown above. Further, Iwanaga discloses the synthesis of an aerogel using methyltrimethoxysilane ([0188]), which would result in a hydrophobic gel having the hydrophobic methyl- and trimethoxysilane functional groups.
Regarding Claim 16, the prior art meets the limitations of Claim 1 as shown above. Further, Iwanaga discloses the average pore size of the produced gel is preferably between 25 and 500 nm ([0074]).
Claim(s) 3, 9-10, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Iwanaga et al. (US 20190100630A1), hereinafter ‘Iwanaga’, in view of US6670402B1, hereinafter ‘Lee’, and Ragheb et al. (US20160243538A1), hereinafter ‘Ragheb’.
Regarding Claim 3, Iwanaga discloses a method of critical point drying a composite material ([0030], [0170]), comprising the steps of
providing a composite material ([0030]) comprising:
a support member, comprising a plurality of pores extending through the support member ([0175], [0180]: a porous support member is provided with the aerogel composite); and
a macroporous cross-linked gel, wherein the macroporous cross-linked gel comprises a polymer formed from a reaction of one or more polymerizable monomers with one or more cross-linkers ([0146]-[0149]: a wet gel is formed by the addition of a base catalyst to a sol solution – by this process, gelation occurs, in which silane monomers are cross-linked and polymerize by the addition of the base catalyst, which is considered a cross-linker. By the polymerization of said silane monomers, a macroporous cross-linked gel is formed; [0074]: the average pore diameter is preferably between 25 and 500 nm – the majority of this range is in the macropore range, and therefore this gel is considered to read upon a macroporous gel);
the macroporous cross-linked gel is located in the pores of the support member ([0181]: the gel is impregnated into the support member, and gelled therein – this would result in gel formed within the pores of the support); and
said macropores of the macroporous cross-linked gel are smaller than the pores of the support member (given that the gel is formed within the pores of the porous support, the pores of the gel within said pores must necessarily be smaller than the pores they occupy in the support); wherein
the composite material is wetted with an aqueous solution ([0128]: the gel obtained is a wet gel, and therefore the gel is wetted with an aqueous solution);
exchanging the aqueous solution with a polar organic solvent, such that the composite material is wetted with the polar organic solvent ([0163]-[0164]: the liquid in the wet gel is exchanged with a polar organic solvent, such as methanol or ethanol);
contacting the composite material with a supercritical fluid at a temperature and a pressure above the critical point of the supercritical fluid, wherein the gaseous and liquid phases are indistinguishable ([0172]: the gel is dried by supercritical drying, wherein the solvent contained in the wet gel is removed by contacting the wet gel with the supercritical fluid at a temperature and pressure equal to or higher than the critical point of the solvent; further, a supercritical fluid is defined as a fluid wherein the gaseous and liquid phases are indistinguishable); and
the polar organic solvent is miscible with the supercritical fluid ([0172]: the use of supercritical CO2 is disclosed for supercritical drying – the polar organic solvents utilized by Iwanaga, such as methanol or ethanol, are known to be miscible in supercritical CO2).
Further regarding Claim 2, while Iwanaga discloses controlling evaporation by maintaining the temperature, thereby critical point drying the composite material ([0171]-[0172]: supercritical drying is performed at a temperature, implying that the chosen drying temperature is maintained for the duration of drying – this is also evidenced by Example 1, where drying occurs at 60 °C and is not disclosed as being adjusted), Iwanaga does not disclose that the pressure is reduced to control evaporation.
Lee discloses methods of more rapidly producing an aerogel product by means of solvent exchange of solvent inside wet gels with supercritical CO2 (Abstract). A person of ordinary skill in the art would have recognized Lee as analogous to Iwanaga, as both references are drawn to the same field of endeavor as the claimed invention, supercritical aerogel drying techniques - a reference is analogous art to the claimed invention if the reference is from the same field of endeavor as the claimed invention, In re Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212.
Further, Lee discloses that once the solvent has been exchanged for supercritical fluid throughout the entire volume of the aerogel, the next step to complete the preparation of the aerogel is to release the pressure in the extractor so that the aerogel can be returned to atmospheric pressure - if the pressure is simply released in an uncontrolled manner, the supercritical fluid will return to a liquid state damaging the aerogels. Lee discloses that supercritical CO2 will tend to cool as it expands unless sufficient heat is supplied to the interior of the gels to prevent the supercritical CO2 from turning into liquid CO2 that will damage the aerogels that have been prepared, and therefore teaches depressurizing the extractor slowly while maintaining the temperature in the reactor above the critical temperature (Col 14, lines 20-42).
Accordingly, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to decrease the pressure while maintaining the temperature in the drying process of Iwanaga, as doing so would prevent damage to the aerogels, thereby preserving the structural integrity thereof.
Further regarding Claim 3, while Iwanaga discloses an aerogel composite as shown above, which is a cross-linked gel disclosed as having potential utility for a wide variety of applications ([0024]), Iwanaga does not disclose that the aerogel comprises ligands that are biological molecules or biological ions as claimed.
Ragheb discloses a composite material comprising a porous support member and a cross-linked gel, wherein the cross-linked gel is located in the pores of the support member ([0007]-[0011]). A person of ordinary skill in the art would have recognized Ragheb as analogous to Iwanaga, as both references are drawn to the same field of endeavor as the claimed invention, the synthesis of supported, cross-linked gels - a reference is analogous art to the claimed invention if the reference is from the same field of endeavor as the claimed invention, In re Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212.
Further, Ragheb discloses use of the inventive composite in chromatography, in which the cross-linked polymer may be functionalized in order to target certain molecules during elution ([0076]) – that is, when the gel is functionalized, the gel will tend to attract target molecules more strongly than non-target molecules, such that the target molecules may be effectively separated from the non-target molecules in a chromatography apparatus. Further, Ragheb discloses that the cross-linked gel may be modified with Protein A in order to achieve monoclonal antibody purification ([0076], [0102], [0282]-[0283]), and that such functionalization resulted in the capability of the modified gel to bind IgG ([0336]), meaning that the functionalization of the gel led to improved separation properties of the gel.
Given this, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to functionalize the aerogel composite of Iwanaga with Protein A by the modification method of Ragheb, as such a modification would have resulted in additional functionality of the aerogel in performing separation and purification of monoclonal antibodies, thus improving the base utility and value of the gel of Iwanaga for chromatographic separations.
Regarding Claims 9-10, the prior art meets the limitations of Claim 1 as shown above. Further, Iwanaga in view of Ragheb makes obvious the functionalization of a cross-linked gel with Protein A, as discussed above.
Regarding Claim 17, the prior art meets the limitations of Claim 1 as shown above. Further, Iwanaga is silent regarding the pore size of the porous support structure.
However, one of ordinary skill in the art would recognize that the pore size of the support structure would affect the volume of silica sol able to impregnate the support, as smaller pores would allow less aerogel into the support, and larger pores would allow more aerogel into the support. As such, one of ordinary skill in the art would have recognized that the pore size of the porous support may be manipulated in order to allow for more or less impregnation of aerogel into the support, therefore determining the aerogel loading of the finally produced composite.
Accordingly, since the instant specification is silent to unexpected results, the specific pore size of the porous support is not considered to confer patentability to the claims. As the aerogel loading is a variable that can be modified, among others, by adjusting the pore size of the porous support, the precise pore size of the support would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the pore size of the porous support in Iwanaga to obtain the desired aerogel loading in the support, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Response to Arguments
Applicant’s arguments, filed 11/25/2025, are acknowledged.
With respect to arguments with regard to the rejection of Claim(s) 8-10 under section 112(b), the arguments have been fully considered and are persuasive. These rejections have been withdrawn.
With respect to arguments in regard to the rejection of Claim 8 under section 112(b) and prior art rejections under section 102, Applicant’s arguments have been fully considered and are persuasive. These rejections are withdrawn.
With respect to arguments in regard to prior art rejections under section 102, Applicant’s arguments 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 section 103.
Further, the arguments of Applicant, as they may apply to the grounds of rejection above, are not considered persuasive. Namely, while the cited prior art does not anticipate the claimed step of controlling evaporation by reducing pressure while maintaining temperature, this feature is obvious over Iwanaga in view of Lee, as shown above.
Conclusion
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/L.E.L./Examiner, Art Unit 1738
/ANTHONY J ZIMMER/Supervisory Patent Examiner, Art Unit 1736