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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/390,449 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims recite essentially identical subject matter to the instant claims, albeit for a blood filter which has specific pore size requirements. The process steps and structure claimed are nevertheless substantially identical, such that any difference is drawn to the intended use of the product.
The reference claims 1 and 2 correspond to instant claim 1, and reference claims 3-15 correspond to reference claims 2-14 respectively. Instant claim 15 represents essentially the product of reference process claims 4-6 and thus is similarly obvious over the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-2, 6, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Black et al (US PGPub 2004/0124092 A1).
With respect to claims 1 and 2, Black teaches a method of forming an inorganic porous membrane [Abs] which is contemplated within the field of biomedical applications including filtration of proteins, viruses, and the like [0004].
Black teaches forming the membrane by providing a first layer (membrane layer) and forming a mask on the membrane layer by, in an embodiment, forming a layer of self-assembled particles of a block copolymer, and subsequently forming pores in the block copolymer by removing a portion of the block copolymer [0008, 0021]. After converting the polymer layer into a mask, the underlying membrane layer is etched through the mask for form uniformly-sized, densely packed pores [0026-0027, Figs. 2A-C & 3]. Black teaches that the pores formed in the polymer layer (and hence the pores etched into the membrane) may be adjusted down to only a few nanometers by appropriate material selection, with high uniformity [0020] and discloses typical diameters of around 20 nm, and ranges available from 2-100 nm [0021] for particular diblock copolymer systems. Further, Black teaches supporting layers in which larger pores are formed via backside etching [Figs. 4A-H & 5A-H] such that the nano-scale layer is suspended on a support of silicon or the like [0028-0029]. This is properly forming a channel through [a] substrate with the first layer provided above the substrate.
These channels extend through the substrate in a direction orthogonal to the first layer i.e. perpendicular to the first layer, passing through it in a thickness direction, with the second end arranged at a bottom of the substrate.
Given the above, the process taught by Black anticipates the claimed process.
With respect to claim 6, Black teaches that the mask can be formed by depositing a PS-PMMA diblock copolymer, such that the PMMA forms cylinders which can be made to orient vertically and then be removed, thereby facilitating pore formation [0021].
With respect to claim 12, as above the copolymer system may be PS-PMMA diblock copolymer.
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 3-5 is rejected under 35 U.S.C. 103 as being unpatentable over Black et al in view of Tang et al (US PGPub 2010/0181288 A1) and Zhang et al (US PGPub 2011/0042301 A1).
Black teaches as above but is silent to a step of depositing a film or oxidizing the inner surfaces of the pores of the first layer.
However, Tang teaches similar micro- and nano-porous filters e.g. formed through making an lithography techniques [Abs] and teaches that it may be desirable to modify the surface conditions of the membranes e.g. by coating the surface and pore interiors with suitable polymer layers [0074-0075]. However, this is taught within the context of polymeric substrates.
Additionally, Zhang teaches that copolymer brushes can be attached to the surface of an inorganic membrane material using a suitable oxide intermediate e.g. silicon dioxide [0035-0036]. However, this is taught within the context of forming mask layers or the like for etching.
It would have been obvious to one of ordinary skill in the art in view of the combined teachings of Tang and Zhang to modify the process of Black to feature formation of an intermediate oxide layer and grafting thereto of polymer brushes or a similar coating layer to modify the surface and/or the pore interiors of the resulting etched membrane; in view of Tang, it would be recognized that this can be carried out in order to modify the membrane to provide more favorable surface properties (e.g. suitable for bioseparations) and, in view of Zhang, it would be recognized that this set of process steps can be adapted for modifying an inorganic substrate with polymer grafts e.g. brushes.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Black et al in view of Bosworth et al (US PGPub 2011/0151236 A1).
Black teaches as above but is silent to embodiments in which the block copolymer forms lamellar domains to form a plurality of slits in the membrane when etched.
However, Bosworth teaches similar processes for forming membranes using block copolymer lithography [Abs] using selectively degraded block copolymers as masks to etch pores into underlying substrates; membranes for e.g. microfluidic applications are contemplated [0008]. Bosworth teaches that copolymers can be provided typically in cylindrical or lamellar configurations [0002] e.g. with or without chemical pre-patterning, including with PS-PMMA copolymer [0046, Fig. 3] which allows for natural or controlled alignment of the lamella to occur, thus producing straight or curved slits [0061]. See MPEP 2143 I.B; a simple substitution of one known copolymer configuration for another, known to be useful for forming masks for etching in production of membranes useful for e.g. filtration, is obvious to one of ordinary skill in the art.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Black et al in view of Yoo et al (US PGPub 2016/0059190 A1).
Black teaches as above but is silent to the production of tapered pores within the first layer.
However, Yoo teaches liquid filtering structures with high filtration efficiency [Abs] using a nanoporous layer, including layers formed via etching [0120], and teaches that the nanopore itself may have e.g. a tapered or bottleneck shape to obtain a minimum diameter of 10 nm or less [0061], such that functionalization when present may be provided only at the point of narrowest diameter. See further MPEP 2144.04 IV.B; changes in shape are generally obvious to those of ordinary skill in the art. The use of tapered pores such as those taught by Yoo in the process of Black would have been obvious e.g. as a standard configuration for pores, or to gain a benefit such as reducing the region for which the diameter is minimized and functionalization is warranted.
Claims 9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Black et al.
With respect to claim 9, Black teaches that membrane pore densities in excess of 109-1012/cm2 are achievable [0020], such that maximization of the fill-factor is at least a contemplated benefit of the taught process; examiner notes that for a pore diameter of about 20 nm, a fill-factor of 40% is understood to require on the order of 3x1011 pores/cm2, such that the fill-factors implied by Black’s contemplated range of densities would at minimum overlap the claimed range for fill-factor. The claimed value would therefore have been obvious to one of ordinary skill in the art e.g. given the overlapping range or, otherwise, given the motivation to optimize the packing density of the pores already contemplated by Black.
With respect to claim 13, Black teaches that selection of appropriate molecular weights and ratios is a result-effective variable which can be used to control the pore size of the copolymer mask (and thus the underlying membrane via etching) [0021]. See MPEP 2144.05 II.A: “’[W]here 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.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The claimed range would have been obvious as an optimization of the result-effective variable discussed by Black.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Black et al in view of Zhang et al.
Black teaches as above but is silent to the thickness of the membrane layer (i.e. the first layer).
However, Zhang teaches similar inorganic membrane devices [Abs] which is formed in part using a pore forming layer of a block copolymer [0024], and teaches that for certain biomedical applications such as virus filtration, nanoscale pores of e.g. 15 nm and membrane thickness of about 100 nm are desirable in order to give the required separation and flux properties [0013].
It would have been obvious to one of ordinary skill in the art to provide a similar thickness to the membrane produced by the process of Black because, as in Zhang, such a thickness gives useful flux for filters in the biomedical field.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Black et al in view of Holweg et al (US PGPub 2017/0030890 A1).
Black teaches as above but is silent to the first layer/substrate including an integrated circuit.
However, Holweg teaches similar filtration devices formed from semiconductor substrates [Abs] and teaches integrating them with substrates containing application-specific integrated circuits which allow for the filters to be combined into sensor applications, e.g. for blood parameter monitoring (glucose levels or the like) [0144].
It would have been obvious to include a similar ASIC structure in the product produced by Black’s method for the same purpose i.e. to allow for production of filters useful in biosensors of various application, as suggested by Holweg.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Black et al in view of Bosworth et al.
See the rejections of claims 1 and 7 above; at least the combination of Black and Bosworth would produce filtration membrane comprising a first layer with pores, and where such pores may include curved slits (in particularly the ”fingerprint”-like patterns discussed by Bosworth regarding uncontrolled alignment of lamellar).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Black et al in view of Bosworth et al, further in view of Tang et al and Zhang et al.
See the discussion of claims 3-5 above. Modification of the membrane to include e.g. polymer brushes on the surface or within the pores would have been obvious in view of the combination of Tang and Zhang e.g. to improve the functionalization of the surface for particular applications.
Conclusion
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/BRADLEY R SPIES/Primary Examiner, Art Unit 1777