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 .
Election/Restrictions
Applicant’s election of Group I (claims 21-32) in the reply filed on July 22, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
The present application is a CON of U.S. App. Serial No. 17/352,015 (U.S. Patent No. 11,920,116), which is a CON of U.S. App. Serial No. 15/769,387 (U.S. Patent No. 11,066,633), which was a 35 U.S.C. 371 national stage filing of the International Application No.
PCT/US2016/058220, filed Oct. 21, 2016. Applicant’s claim for the benefit of a prior-filed parent provisional application 62/244,963 filed on Oct. 22, 2015 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is Oct. 22, 2015.
Information Disclosure Statement
The information disclosure statements, both filed Apr. 16, 2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs have been considered by the examiner.
Claim Objections
Claim 24 is objected to because of the following informalities: the claim recites “are perfused stromal media…”. There appears to be an “in” missing – “are perfused in stromal media…”. Appropriate correction is required.
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 21-32 are rejected under 35 U.S.C. 103 as being unpatentable over Ingber et
al. (U.S. Patent App. No. 2014/0093905 A1, cited in IDS filed on April 16, 2024) in view of Yoo et al. (U.S. Patent App. No. 2011/0212501 A1, cited in IDS filed on April 16, 2024).
The claims are directed to a microdevice which has an upper microchannel that includes cervical epithelial cells and a lower microchannel that includes three lanes, two side lanes including stromal media and a central lane lined with uterine fibroblasts and smooth muscle cells embedded in hydrogel.
With respect to independent claim 21, Ingber et al. teach a microfluidic device for culturing cells (abstract) that includes an upper microchannel that includes live epithelial cells (Figs. 2B-C, microchannel 230 has epithelial cells that are delivered through inlet port 210 (paras. [0073], [0078], [0088]); a lower microchannel that includes two parallel lanes (Fig. 2D, lower body 206, parallel lanes 242, paras. [0077], [0089]) that include stromal media (para. [0011]), and the two, parallel lanes are lined with vascular endothelial cells. (para. [0043], [0136]). Ingber et al. teach three parallel lanes (Fig. 2D, central lane 240, para. [0089]), that fibroblasts can be used (para. [0049], [0125]) and that uterine endometrial ciliated cells can be present in the third lane (para. [0137]). Ingber et al. teach that smooth muscle cells can be used (para. [0049],[0139]). Ingber et al. teach that the three lanes are separated by protrusions (Fig. 2d, walls 244 separate lanes 240 and 242). Ingber et al. teach a porous membrane in between the upper microchannel and lower microchannel (Abstract; Fig. 2B porous membrane 208, para. [0087]), configured to allow nutrients to pass between the upper and lower microchannel. (paras. [0021], [0054], [0060]). Ingber et al. teach that specialized cells, such as fibroblasts and other stem cells can be used, and that medium that appropriate for the cells, such as stem cell SFM (serum free medium) may be used (paras. [0125]-[0126], rendering obvious the inclusion of stomal medium (which would be present to support stromal stem cells or fibroblasts, both of which are included in the teachings of Ingber et al.)
Ingber et al. does not teach cervical epithelial cells, though they generally teach the microdevice can be used to co-culture different cell types, allowing it to mimic human organs, such as lung. (Title, para. [0003], [0018]). Ingber et al. does not teach a third lane in the lower microchannel having uterine fibroblasts and smooth muscle cells embedded in hydrogel.
Yoo et al. teach a three-dimensional hydrogel cell culture device (Abstract) where epithelial cells are cultured and indicate the cells can be cells from the cervix (para. [0113]) and HeLa cells (cervical cancer cells) may be used. (para. [0103]). Yoo et al. further teach that smooth muscle cells are embedded in hydrogel. (paras. [0011], [0101)).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have modified the teachings of Ingber et al. to incorporate cervical epithelial cells in an upper microchannel and uterine fibroblasts and live smooth muscle cells in a third parallel lane of a lower microchannel, allowing the microfluidic device to be used to mimic a cervix, because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Incorporating cervical epithelial cells (as taught by Yoo et al.) in the organ mimicking microdevice taught by Ingber et al. would have led to predictable results with a reasonable expectation of success because Ingber et al. specifically teach that their microfluidic device is intended to be used to reproduce organs, and can be lined with epithelial and endothelial cells and Yoo et al. teach that cervical cells can be cultured in microfluidic devices intended to mimic different organs, including the cervix.
With respect to claim 22, Ingber et al. teach the porous membrane is configured to allow nutrients to pass between the upper and lower microchannel. (para. [0021], [0054], [0060]).
With respect to claim 23, Ingber et al. teach upper and lower microchannels have separate inlets through which materials can be injected (Fig. 2B, inlets 210, 218 allow for injecting into upper and lower lanes, para. [(0073]).
With respect to claim 24, Ingber et al. further teach that cells in the upper microchannel may be perfused with different medium than those in the lower microchannel (para. 0114], rendering obvious perfusing upper microchannel with epithelial cells with epithelial media and perfusing lower microchannel with stromal media in the first side lane and the second side lane.
With respect to claims 25 and 26, Ingber et al. further teach the first and second side lanes can include endothelial cells (paras. [0111]-[0112]); combined with the Ingber et al.’s teaching that the microdevice can be used to reproduce organs, and can be lined with epithelial and endothelial cells, this modification would be obvious.
With respect to claims 27-30, these variants of the porous membrane are either taught or rendered obvious by Ingber et al., who teaching indicate that the porous membrane may include numerous art-recognized modifications, including the addition of biomaterial, such as decellularized extracellular matrix. (paras. [0087], [0106], [0121]). Ingber et al. also teach the porous membrane may be made of PDMS, which is optically transparent. (para. [0159]).
With respect to claims 31 and 32, Ingber et al. further teach that ECM proteins, including various collagen types (which would include collagen type 1), can be used; ([0121]) and micropatterning can also be incorporated. (paras. [0106], [0157]).
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.
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 21-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1-13 of U.S. Patent No. 11,066,633 (the ‘633 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the application claims are taught within the claims of the '633 Patent. Claim 1 of the '633 Patent
teaches most of the limitations in the application. Claims 2 and 4 of the '633 Patent supply the
missing limitations of the present claims.
Claims 21-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1-13 of U.S. Patent No. 11,920,116 (the ‘116 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the application claims are taught within the claims of the '116 Patent. Claim 1 of the '633 Patent teaches most of the limitations in the application. Claims 4 and 5 of the '633 Patent supply the missing limitations of the present claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4.
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/TERESA E KNIGHT/ Primary Examiner, Art Unit 1634
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