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. Claim Objections Claims 8 and 16 are objected to because of the following informalities : Claim 8 recites "coagulative polymeric microfiber" (singular) in the preamble, which is inconsistent with the parent claim 1's recitation of "coagulative polymeric microfibers" (plural). This inconsistency renders the scope of the claim unclear. Claim 16 recites "a a polylactide-co- glycolide " with a duplicated article "a." This appears to be a typographical error . Appropriate correction is required. 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 appl icant regards as his invention. Claim s 7, 12, and 15 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 . Claims 7, 12, and 15 each recite that the hydrophilic hydrogel thin film is "coated on the surface of the outer microcatheter located in the single lumen part." The single lumen part is defined in the independent claims as being "formed by the outer microcatheter from an end of the inner microcatheter to an end of the outer microcatheter." In other words, the single lumen part is the interior space within the outer microcatheter. The claims appear to recite coating the outer surface of the outer microcatheter in a region that is inside the outer microcatheter itself, which is a physical impossibility. If the applicant intended to recite coating the inner surface of the outer microcatheter within the single lumen part, the claims should be amended accordingly. As currently drafted, the claims are considered vague . 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. Claims 1-5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (KR102456586B1; hereinafter “ L im”) in view of Greff et al. (US 5,851,508A; hereinafter “Greff”), the Onyx FDA Summary , and the publication Yang et al. (hereinafter “Yang & Guo ”) . In relation to independent claim 1 , Lim shows in figures 1(a) and 1(b) above, an apparatus for continuous spinning of microfibers comprising: an outer microcatheter (outer micro-conduit 115) ; an inner microcatheter (inner micro-conduit 125) having a smaller diameter than the outer microcatheter and inserted inside the outer microcatheter ; a double lumen part (120) in which the outer microcatheter and the inner microcatheter are coaxially superimposed with a radially spaced interstitial space ; and a single lumen part (110) formed by the outer microcatheter from an end of the inner microcatheter to an end of the outer microcatheter . Lim further teaches: "First, the hydrogel precursor solution is supplied to flow as a sample fluid through the internal micro-conduit 125 of the flexible microfluidic device 100, and saline or a fluid that can be used in the human body is supplied as a cover fluid through the external micro-conduit 115. When supplied to flow, the sample fluid and the sheath fluid may meet and combine with each other in a single lumen portion 110. At this time, the hydrogel precursor is dominated by laminar flow and diffusion, which are the dominant phenomena at the micro-scale, and is stretched by a 3D coaxial sheath flow stream formed around it ” ( see Lim translation, page 4, 7 th paragraph, line 28 from the top of page 4). “The stretched hydrogel precursor solution flows into the outlet of the flexible microfluidic device 100 and is exposed to light L emitted at a specific angle from the optical fiber 130” (see Lim translation, page 4, 8 th paragraph, line 33 from the top of page 4). Lim does not disclose that the core fluid is a coagulative polymeric fluid. Instead, Lim teaches a photocurable hydrogel precursor as the core fluid, which is solidified by UV light delivered through an integrated optical fiber. However, Greff discloses a liquid embolic composition comprising an ethylene vinyl alcohol copolymer (EVOH) (see Greff; Abstract and col. 7, lines 59-60) dissolved in dimethyl sulfoxide (DMSO) (Greff; col. 8, lines 61-67) , which is a coagulative polymeric fluid . Greff teaches that this fluid is delivered through a microcatheter for embolization (see Greff; Example 5, lines 53-56) and that it precipitates in situ upon contact with an aqueous environment, forming a coherent embolus (see Greff; claim 7, last two lines of claim 8) . Moreover [in order to further clarify this capability] , t he Onyx FDA Summary confirms this mechanism, stating: "The DMSO solvent dissipates into the blood, causing the EVOH copolymer and suspended tantalum to precipitate in situ into a spongy, coherent embolus" (Onyx FDA Summary; page 9, starting in line 5 from the top of page 9). Finally, the publication Yang & Guo teaches the microfluidic spinning of EVOH into microfibers using a coaxial microfluidic setup: "constructed by coaxially aligning two cylindrical glass capillaries inside a square glass capillary (Figure 1a). For simplicity, here, the inner phase was... 8.0 wt % EVOH in dimethyl sulfoxide (DMSO)... Liquid poly( ethylene glycol) 400 (PEG400)... was used as the outer phase... These two liquids were pumped separately into the inner and outer channels...solid polymeric helical fibers automatically formed..." ( Yang & Guo; p age 2 of 6, first column, lines 1-17 ) . Based on the above comments, i t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Lim by substituting the photocurable hydrogel core fluid with the coagulative polymeric fluid (EVOH/DMSO) of Greff. The motivation to do so would be to eliminate the need for an optical fiber and UV light source, thereby simplifying the apparatus while still achieving in situ microfiber formation for aneurysm embolization. Both Lim and Greff are directed to the same field of endeavor (endovascular embolization via microcatheter), and Yang & Guo explicitly demonstrates that EVOH can be formed into microfibers via microfluidic spinning. The substitution of one known solidification mechanism (photocuring) for another (solvent-exchange coagulation) to achieve the same result (in situ microfiber formation) would have been a predictable variation well within the skill of the ordinary artisan. In relation to independent claim 9 , Lim discloses a method for continuous spinning of microfibers using the same apparatus structure recited in claim 1 [see claim 1 analysis above] . Additionally, Lim discloses the steps of: " transferring the cover fluid from the outside of the inner microconduit through the inner space of the outer microconduit ; and irradiating light from the single lumen portion to the end of the inner microconduit using the optical fiber; transferring the hydrogel precursor solution to the sample fluid through the internal space of the internal microconduit ." (see Lim translation, page 13, last paragraph ). As discussed in the analysis of claim 1 , Lim does not disclose that the core fluid is a coagulative polymeric fluid. Instead, Lim teaches a photocurable hydrogel precursor as the core fluid, which is solidified by UV light delivered through an integrated optical fiber. However, Greff discloses a liquid embolic composition comprising an ethylene vinyl alcohol copolymer (EVOH) (see Greff; Abstract; col. 7, lines 59-60) dissolved in dimethyl sulfoxide (DMSO) (Greff; col. 8, lines 61-67) , which is a coagulative polymeric fluid . Greff teaches that this fluid is delivered through a microcatheter for embolization (see Greff; Example 5, lines 53-56) and that it precipitates in situ upon contact with an aqueous environment, forming a coherent embolus (see Greff; claim 7, last two lines of claim 8) . Moreover, the Onyx FDA Summary confirms this mechanism, stating: "The DMSO solvent dissipates into the blood, causing the EVOH copolymer and suspended tantalum to precipitate in situ into a spongy, coherent embolus" (Onyx FDA Summary; page 9, starting in line 5 from the top of page 9). Finally, the publication Yang & Guo teaches the microfluidic spinning of EVOH into microfibers using a coaxial microfluidic setup: " constructed by coaxially aligning two cylindrical glass capillaries inside a square glass capillary (Figure 1a). For simplicity, here, the inner phase was... 8.0 wt % EVOH in dimethyl sulfoxide (DMSO)... Liquid poly( ethylene glycol) 400 (PEG400)... was used as the outer phase... These two liquids were pumped separately into the inner and outer channels...solid polymeric helical fibers automatically formed..." ( Yang & Guo; p age 2 of 6, first column, lines 1-17 ) . Based on the above comments, i t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Lim by substituting the photocurable hydrogel core fluid with the coagulative polymeric fluid (EVOH/DMSO) of Greff. The motivation to do so would be to eliminate the need for an optical fiber and UV light source, thereby simplifying the apparatus while still achieving in situ microfiber formation for aneurysm embolization. Both Lim and Greff are directed to the same field of endeavor (endovascular embolization via microcatheter), and Yang & Guo explicitly demonstrates that EVOH can be formed into microfibers via microfluidic spinning. The substitution of one known solidification mechanism (photocuring) for another (solvent-exchange coagulation) to achieve the same result (in situ microfiber formation) would have been a predictable variation well within the skill of the ordinary artisan. In relation to claim 2 , Lim discloses a support (135) secured between the outer micro-conduit and the inner micro-conduit to maintain the spacing between them: "Also, a support 135 disposed to be spaced apart from the optical fiber 130 in the circumferential direction of the inner micro conduit 125 may be inserted between the outer micro conduit 115 and the inner micro conduit 125" (se e Lim translation, page 8 , 9 th paragraph, line 35 from the top of page 8 ). Since this enhancement would have been considered well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus. In relation to claim 3 , Lim discloses a support: " [ i ] t may further include at least one support disposed between the outer micro-conduit and the inner micro-conduit to be spaced apart from the optical fiber in a circumferential direction of the inner micro-conduit" (se e Lim translation, page 6 , 10 th paragraph, line 30 from the top of page 6 ). Since this enhancement would have been considered well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus. In relation to claim 4 , Lim discloses that the support (135) is positioned in the double lumen part (120) with an end of the support disposed adjacent to the distal end of the inner microcatheter: " [t] he end of the support may be configured to coincide with the end of the inner microconduit in the double lumen portion or to be shorter than the end of the inner microconduit " (se e Lim translation, page 6 , 11 th paragraph, line 32 from the top of page 6 ). Since this enhancement would have been considered well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus. In relation to claim 5 , Lim discloses that the outer and inner microcatheters are made of a fl exible material: " [t] he outer micro conduit and the inner micro conduit may be made of a flexible material" (see Lim translation, page 6, 1 3 th paragraph, line 3 5 from the top of page 6). Since this enhancement would have been considered well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus. Claims 6 -7, 11-12, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (KR102456586B1; hereinafter “ L im”) in view of Greff et al. (US 5,851,508A; hereinafter “Greff”), the publication Yang et al. (hereinafter “Yang & Guo”) and the Onyx FDA Summary , as discussed above, and in further view of Lim et al. (KR20200127489A; hereinafter “Lim '489 ”) . In relation to claim 6 , Lim discloses the apparatus of claim 1 (as discussed above) but does not disclose a hydrophilic hydrogel thin film coated on a surface of the outer microcatheter. However, Lim '489 discloses coating the surface of a medical device (an artificial vascular model) with a hydrophilic hydrogel thin film (lubricating layer) to reduce friction (Lim 489; Abstract and page 4, line 7) . The hydrogel coating is formed using benzophenone pretreatment (Lim 489; page 6, line 12) and UV-cured acrylamide-based hydrogel (Lim 489; page 8, line 15) . Therefore, it would have been obvious to one of ordinary skill in the art to apply the hydrophilic hydrogel thin film coating of Lim '489 to the outer microcatheter of the apparatus of Lim. The motivation to do so would be to reduce friction and prevent the newly formed coagulative polymeric microfiber from adhering to the inner wall of the outer microcatheter as it is generated and discharged through the single lumen part. This is a known problem in the liquid embolic art (catheter adhesion) and the hydrogel coating is a known solution to reduce surface friction and adhesion in medical devices. In relation to claim 7 , as discussed in the § 112(b) analysis, this claim is indefinite because it recites coating the surface of the outer microcatheter "located in the single lumen part," which is a physical impossibility as drafted. Assuming the claim is intended to recite coating the inner surface of the outer microcatheter within the single lumen part, this limitation would be obvious over the combination of Lim, Greff, Yang & Guo, and Lim '489. The motivation to coat specifically the inner surface in the single lumen part would be to prevent the coagulative microfiber from adhering to the catheter wall in the region where it is being formed. In relation to claim 11 , t he analysis is the same as for claim 6. The hydrophilic hydrogel thin film coating is not taught by Lim but is taught by Lim '489. The motivation to combine is the same as discussed for claim 6. In relation to claim 12 , as discussed in the § 112(b) analysis, this claim is indefinite because it recites coating the surface of the outer microcatheter "located in the single lumen part," which is a physical impossibility as drafted. Assuming the claim is intended to recite coating the inner surface of the outer microcatheter within the single lumen part, this limitation would be obvious over the combination of Lim, Greff, Yang & Guo, and Lim '489. The motivation to coat specifically the inner surface in the single lumen part would be to prevent the coagulative microfiber from adhering to the catheter wall in the region where it is being formed. In relation to independent claim 13 , as explained in the analysis of independent claim 1 , Lim discloses (a) all the structural e lements of claim 13 and (b) the use of a core fluid [hydrogel precursor solution] and a sheath fluid [saline], Greff and Yang & Guo disclose the use of a core fluid [ ethylene vinyl alcohol copolymer (EVOH) ] and a sheath fluid [ dimethyl sulfoxide (DMSO) ] to generate a coagulative polymeric microfiber, and as discussed in claim 6 , Lim '489 discloses coating the surface of a medical device with a hydrophilic hydrogel thin film (lubricating layer) to reduce friction (Lim 489; Abstract and page 4, line 7). The motivations to combine the cited references are the same as discussed for claims 1 and 6 . Conclusively, the combination of Lim, Greff, Yang & Guo, Onyx FDA Summary, and Lim '489 teaches all the elements of claim 13. In relation to claim 14 , Lim discloses a support (135) secured between the outer and inner microcatheters: "Also, a support 135 disposed to be spaced apart from the optical fiber 130 in the circumferential direction of the inner micro conduit 125 may be inserted between the outer micro conduit 115 and the inner micro conduit 125." (se e Lim translation, page 8 , 9 th paragraph, line 35 from the top of page 8 ). Since this enhancement would have been considered well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus. In relation to claim 15 , as discussed in the § 112(b) analysis, this claim is indefinite because it recites coating the surface of the outer microcatheter "located in the single lumen part," which is a physical impossibility as drafted. Assuming the claim is intended to recite coating the inner surface of the outer microcatheter within the single lumen part, this limitation would be obvious over the combination of Lim, Greff, Yang & Guo, and Lim '489. The motivation to coat specifically the inner surface in the single lumen part would be to prevent the coagulative microfiber from adhering to the catheter wall in the region where it is being formed. Claim s 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (KR102456586B1; hereinafter “ L im”) in view of Greff et al. (US 5,851,508A; hereinafter “Greff”), the publication Yang et al. (hereinafter “Yang & Guo”) and the Onyx FDA Summary , as discussed above, and in further view of Duocastella et al. (WO 2020/099190A1; hereinafter “ Duocastella ”) . In relation to claim s 8 and 10 , Lim does not disclose the specific coagulative polymeric fluids recited in claim 8. As discussed above, Greff discloses a liquid embolic composition comprising an ethylene vinyl alcohol copolymer (EVOH) (see Greff; Abstract; col. 7, lines 59-60) dissolved in dimethyl sulfoxide (DMSO) (see Greff; col. 8, lines 61-67) , which is a coagulative polymeric fluid . Duocastella also discloses the use of an EVOH solution (dissolved in DMSO) as a liquid embolic agent (see Duocastella ; page 2, starting in line 27 to page 3, line 13). Since this enhancement would have been considered well- known in the art at the time of filing, its i mplementation in the invention would have been considered an obvious alternative in the design of the apparatus. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (KR102456586B1; hereinafter “ L im”) in view of Greff et al. (US 5,851,508A; hereinafter “Greff”), the publication Yang et al. (hereinafter “Yang & Guo”) and the Onyx FDA Summary , as discussed above, and in further view of Lim et al. (KR20200127489A; hereinafter “Lim 489”) and Duocastella et al. (WO 2020/099190A1; hereinafter “ Duocastella ”) . Lim discloses that the sheath fluid can include saline: " [t] he sample fluid may be a hydrogel precursor, and the cap fluid may be a saline-based fluid or a fluid usable in the human body." (see Lim translation, page 3, line 29). Lim does not disclose the specific coagulative polymeric fluids (EVOH , etc.) . As discussed for claims 8 and 10 above, Greff and Duocastella t each EVOH/DMSO . Therefore, since this enhancement would have been considered well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MANUEL A MENDEZ whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-4962 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri 7:00 AM-5:00 PM . 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, FILLIN "SPE Name?" \* MERGEFORMAT Bhisma Mehta can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-3383 . 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. Respectfully submitted, /MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783