CTNF 18/395,615 CTNF 92208 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 1-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Makarova et al (US PGPub 2013/0059308 A1) in view of Hahn et al (EP 3056260 A1) and Waller, Jr. et al (US PGPub 2024/0066473 A1 – also available as WO 2021/124011 A1) . With respect to claim 1 , Makarova teaches microfilter membranes formed from photo-definable films [Abs] using masking/patterning techniques to produce apertures; the films may be produced in embodiments with pores ( through-holes ) which are uniform in size, depending upon the intended application [0071] with cross-sections in various shapes such as circular cross sections. The ability to provide highly uniform pores is identified as a benefit of the process [0070]. In embodiments, these pores are highly uniform in size and highly perpendicular to the surface of the material [0075]. This properly represents a structure with first and second main surfaces and through-holes penetrating between the two [Figs. 9A-B; Figs. 10A-B]. Makarova essentially differs from the instant claimed invention in that Makarova does not quantify the pore uniformity e.g. to ensure a consistency of pore area at 10% and 90% (“a” and “b”) thickness positions in the layer such that ratio of the two areas is in a range of 0.8-1.25, or that the deviation from such range is 3.0% or less in either direction. 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). See further Hahn, which teaches production of separation membranes [0002] which has, ideally, an isoporous character i.e. as narrow as possible a pore size distribution [0004]. Hahn characterizes this as having e.g. at least 90% of the pores falling within a +- 15% range of the average diameter, and teaches that this provides good separation sharpness (cutoff) for the membrane [0051]. As such, particularly given that Makarova already teaches embodiments in which uniformity is desired, it would have been obvious to one of ordinary skill in the art to optimize the uniformity/isoporosity of the pores in view of Hahn because, as in Hahn, highly isoporous membranes with very narrow pore size distributions beneficially improve the separation properties of the membrane. Further, in view of Hahn, it would have been obvious to consider this value both in terms of magnitude of deviation and in terms of quantity of outliers. If Hahn is considered insufficient for determining consistency between first and second sides of the membrane surface i.e. “a” and “b” positions, see further Waller, Jr. which teaches isoporous membranes similar to those taught by Hahn [Abs], and teaches that it is desirable for the isoporosity to extend throughout the entire thickness of the membrane separating layer [0028-0029]. As such, it would further have been obvious to ensure that the uniformity (as already taught by Makarova)/isoporosity (discussed by Hahn) applies to the entire thickness i.e. that the “a” and “b” positions are consistent with each other and have the same diameter with very low deviation. The claimed invention would have been obvious to one of ordinary skill in the art in view of such optimizations. With respect to claim 2 , as above Makarova teaches highly perpendicular pores; as above, optimization to ensure high uniformity would have been obvious i.e. to a standard of 99% consistency or the like. With respect to claims 3 and 4 , as above optimization to achieve very narrow size (diameter) distribution would have been obvious e.g. in view of Hahn. With respect to claim 5 , Makarova does not explicitly teach that the ends of the pores have a curve of high radius (i.e. a very gentle curve). However, because Makarova teaches the same method of production as the instant application (see further the rejection of claim 16 below), the process would produce the same features regarding the pore geometry e.g. mild curvature at the surfaces or the like. See also MPEP 2144.04 IV.B; changes in shape are generally obvious to those of ordinary skill in the art, and selection of an appropriate entry/exit geometry to form stable pores of desired character represent obvious engineering choices for one of ordinary skill in the art. An alternative discussion of the limitations is provided below in view of Bowen. With respect to claim 6 , Makarova teaches 7-8 micron pores as an example embodiment useful for particular application [0071]. With respect to claim 7 , Hahn [0002] and Waller, Jr. [0127] teach that smaller pore sizes may similarly be useful for isoporous membranes e.g. for ultrafiltration applications or the like, with average pore sizes of 0.1 micron or less. As such, provision of smaller pore sizes in the membranes of Makarova would have been obvious to facilitate applications such as those contemplated by Hahn and Waller, Jr. With respect to claim 8 , as above Makarova teaches various pore geometries including circular cross-sections. With respect to claim 9 , Makarova teaches that, from the perspective of managing filtration pressure requirements, it is desirable to manage the thickness to be in a range of e.g. 8-14 microns for some applications [0074] which overlaps the claimed range such that the claimed range would have been obvious to one of ordinary skill in the art. With respect to claim 10 , Makarova teaches that the membranes may be produced with hydrophilic surfaces which implies a contact angle in a range of 0-90⁰ i.e. overlapping the claimed range such that the claimed range would have been obvious to one of ordinary skill in the art [0090]. Waller, Jr. similarly teaches production of hydrophilic membranes [0056]. With respect to claim 11 , Makarova teaches an epoxy-based “photo-definable” ( photosensitive ) composition for forming the layer, thus facilitating the patterning process etc. [0038]. With respect to claim 12 , see the rejections of claims 1-10 above; the claim limitations are either directly taught by Makaraova or would have been obvious to one of ordinary skill in the art over the teachings of Makarova, Hahn, and/or Waller, Jr. With respect to claims 13, 14, and 17 , Makarova teaches that the material may be a negative resist [0041] or a positive resist [0043] in various embodiments. With respect to claim 15 , Makarova contemplates cell separation applications [0071]. Regardless, Examiner notes that intended use language in apparatus claims is not accorded patentable weight where the statement of intended use does not distinguish over the prior art apparatus (MPEP 2114.II). With respect to claim 16 , Makarova teaches patterning via a mask, as discussed above, to produce pores; further, after patterning, Makarova teaches exposing to a developer to fully form the membrane [0040-0045, Figs. 1A-1E]. With respect to claim 19 , Makarova teaches exposing the material through a photomask (199) with a pattern (198) [0040] . 07-21-aia AIA Claim s 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Makarova et al in view of Hahn et al and Waller, Jr. et al, further in view of Bowen et al ( Prediction of optimum membrane design: pore entrance shape and surface potential , Colloids and Surfaces, 2002) . See the rejections of claims 5 and 12 above. If the curvature of the entrance of the pore is not considered an inherent result of the process of patterning and forming the pores via the process of Makarova and of the instant invention, and is considered beyond a simple design choice of routine selection by one of ordinary skill in the art, designing such a feature would nevertheless have been obvious to one of ordinary skill in the art in view of Bowen. Bowen teaches particle rejection in microfiltration and ultrafiltration membrane [Abs] and teaches that, for production of the most effective membrane (and geometry which produces the most favorable critical filtration velocity), the use of a rounded pore entrance is optimal [Fig. 2; Sec. 4, Conclusions]. As such, intentional production of intentionally curved pore entrances would have been obvious in the membranes of Makarova. Bowen analyzes rounded entrances in which the radius of curvature equals the radius of curvature of the pore itself, which in the case of Makarova would suggest a radius of curvature of greater than 1 micron (i.e. 7-8 microns or the like) but, regardless, Bowen teaches that other dimensions are workable [Sec. 3, Results and discussion] . 07-21-aia AIA Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Makarova et al in view of Hahn et al and Waller, Jr. et al, further in view of Yonezawa et al (US PGPub 2017/0115564 A1) . Makarova teaches forming pores by exposing a material to light through a mask, and teaches that this may be UV light [0051]. Makarova is silent to specific wavelengths e.g. those that would represent “i-rays” (understood to be around 365 nm). However, Yonezawa teaches forming films of high reliability using photosensitive compositions [Abs] and teaches that i-rays represent a preferred example of the light source e.g. from an appropriate LED or lamp [0313]. Because Makarova does not particularly limit the wavelengths employed, it would have been obvious to one of ordinary skill in the art to look to the art to find useful radiation sources for film formation and, in view of Yonezawa, to employ i-rays . 07-21-aia AIA Claim s 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Makarova et al in view of Hahn et al and Waller, Jr. et al, further in view of Nakazawa et al (US PGPub 2015/0155363 A1) . With respect to claim 20 , Makarova teaches forming the membrane layer on top of a substrate such as a metallic foil, and then removing the substrate chemically or by “well-known methods” [0046]. Makarova does not explicitly teach that these include physical peeling. However, physical peeling of layers of films and the like from substrates is well known in the art. Nazakawa teaches semiconductor films [Abs] which may be formed using patterning and masks [0287] and teaches that the material may be removed from a temporary support substrate by physical separation, e.g. with the assistance of an adhesive layer to facilitate separation [0625]. It would have been obvious to one of ordinary skill in the art to employ a physical peeling step because, as above, Makarova contemplates “well-known methods” and, in view of Nazakawa, physical separation of a support substrate from a patterned layer is known to be useful in the art. With respect to claims 21 and 22 , Makarova teaches generally that developer (step P3) may be applied before or concurrent with the removal of the substrate (step P4). However, see also MPEP 2144.04 IV.C; changes in the order of performing process steps represent obvious modifications for one of ordinary skill in the art. With respect to claims 23 and 24 , Nazakawa teaches that the adhesive layer may be a water-soluble material [0625]. As such, provision of a water soluble support or at least a water soluble intermediate would have been an obvious means of facilitating easy removal of the membrane of Makarova from the support, in particular because Makarova already contemplates chemical separation of the support layer. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY R SPIES whose telephone number is (571)272-3469. The examiner can normally be reached Mon-Thurs 8AM-4PM. 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, Jennifer Dieterle can be reached at (571)270-7872. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BRADLEY R SPIES/Primary Examiner, Art Unit 1777 Application/Control Number: 18/395,615 Page 2 Art Unit: 1777 Application/Control Number: 18/395,615 Page 3 Art Unit: 1777 Application/Control Number: 18/395,615 Page 4 Art Unit: 1777 Application/Control Number: 18/395,615 Page 5 Art Unit: 1777 Application/Control Number: 18/395,615 Page 6 Art Unit: 1777 Application/Control Number: 18/395,615 Page 7 Art Unit: 1777 Application/Control Number: 18/395,615 Page 8 Art Unit: 1777 Application/Control Number: 18/395,615 Page 9 Art Unit: 1777
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