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 7-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,453,848. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claim is merely broader than the patent claim. Here, all of the elements of application claims 7-26 are found in patent claims 1-16. The difference between the claims is that the patent claims include many more elements and thus are much more specific. Thus, the invention of claims 1-16 of the patent is in effect a “species” of the “generic” invention of application claims 7-26. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims 7-26 are anticipated by patent claims 1-16, the claims are not patentably distinct.
Claim Rejections - 35 USC § 102
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 7-12, 14-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grego et al. (Pub. No.: US 2014/0335496).
For claim 7, Grego et al. (hereinafter, Grego) discloses a multi-layer biomimetic organ model (e.g., fig. 5A, 5B) comprising:
at least two channel slabs (fig. 5A, upper and lower slabs), each comprising at least one microchannel 502, 518 (e.g., Table 1 for dimensions on the micron scale);
at least one chamber slab (fig. 5A, where chamber 506 is located) comprising at least one chamber 506 exposed at each of a first surface of the at least one chamber slab and a second surface of the at least one chamber slab (e.g., fig. 5A, 5B); and
a gel layer (e.g., para. 12) disposed in the at least one chamber (e.g., para. 44) of the at least one chamber slab, the gel layer having a first side facing at least one microchannel of a first one of the at least two channel slabs and a second side facing at least one microchannel of a second one of the at least two channel slabs,
wherein the at least one microchannel in each of the at least two channel slabs are in fluid communication through the gel layer (para. 44, fig. 5A, 5B).
For claim 8, Grego discloses the multi-layer biomimetic organ model of claim 7, wherein an internal surface of the at least one chamber, between the first surface and the second surface, is uninterrupted (e.g., fig. 5A, 5B).
For claim 9, Grego discloses the multi-layer biomimetic organ model of claim 8, wherein the gel layer is anchored on the internal surface of the at least one chamber (e.g., para. 44).
For claim 10, Grego discloses the multi-layer biomimetic organ model of claim 9, wherein the gel layer is anchored on the internal surface of the at least one chamber based on a desired contraction time of the gel layer (e.g., para. 46).
For claim 11, Grego discloses the multi-layer biomimetic organ model of claim 7, wherein the at least two channel slabs and the at least one chamber slab individually comprise glass, metal, alloy, plastic, wood, paper, or a polymer (para. 55).
For claim 12, Grego discloses the multi-layer biomimetic organ model of claim 7, wherein one or more of the at least one microchannel has a width from 0.01 nm to 1 cm (Table 1).
For claim 14, Grego discloses the multi-layer biomimetic organ model of claim 7, wherein the gel layer is embedded with tissue or cells (para. 44).
For claim 15, Grego discloses the multi-layer biomimetic organ model of claim 14, wherein the tissue or cells comprise basal stromal tissue or basal stromal cells (para. 28).
For claim 16, Grego discloses the multi-layer biomimetic organ model of claim 7, wherein the gel layer comprises extracellular matrix proteins selected from the group consisting of collagen, fibronectin, laminin, hyaluronic acid, and mixtures thereof (para. 9).
For claim 17, Grego discloses the multi-layer biomimetic organ model of claim 7, wherein the gel layer further comprises at least one type of macrophages, dendritic cells, microbial cells, fibroblasts, endothelial cells, blood monocytes, pericytes, stem cells, immune cells, muscle cells, neural cells, or mixtures thereof (para. 9).
For claim 18, Grego discloses the multi-layer biomimetic organ model of claim 7 further comprising a layer of cells contacting the first side of the gel layer (para. 9).
For claim 19, Grego discloses the multi-layer biomimetic organ model of claim 18, wherein the layer of cells coating the first side of the gel layer comprises epithelial cells (para. 9)
For claim 20, Grego discloses the multi-layer biomimetic organ model of claim 19, wherein the epithelial cells comprise pulmonary epithelial cells, hepatic epithelial cells, or renal epithelial cells (para. 6).
For claim 21, Grego discloses the multi-layer biomimetic organ model of claim 7 further comprising a layer of cells contacting the second side of the gel layer (para. 6).
For claim 22, Grego discloses the multi-layer biomimetic organ model of claim 21, wherein the layer of cells contacting the second side of the gel layer comprises endothelial cells (para. 6).
For claim 23, Grego discloses the multi-layer biomimetic organ model of claim 7, wherein the gel layer is perfused only by fluid flow from one or more of the at least one microchannel disposed in each of the at least two channel slabs (fig. 5A, 5B).
For claim 24, Grego discloses the multi-layer biomimetic organ model of claim 19, wherein the layer of cells contacting the first side of the gel layer further comprises at least one type of macrophages, dendritic cells, microbial cells, or mixtures thereof (para. 44).
For claim 25, Grego discloses the multi-layer biomimetic organ model of claim 22, wherein the layer of cells contacting the second side of the gel layer further comprises at least one type of macrophages, dendritic cells, microbial cells, or mixtures thereof (para. 44).
For claim 26, Grego discloses the multi-layer biomimetic organ model of claim 7 further comprising a first layer of cells contacting the first side of the gel layer and a second layer of cells contacting the second side of the gel layer, wherein the first layer of cells and the second layer of cells are obtained from the same organ (para. 6).
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Grego et al. (Pub. No.: US 2014/0335496).
For claim 13, Grego discloses the first microchannel or second microchannel have a width from 0.01 nm to 1 cm (Table 1). However, Grego does not specify the microchannel has a length from 1 mm to 10 mm. Given the area and volume dimensions in Table 1, it would have been highly obvious to have selected a microchannel length from 1 mm to 10 mm as an obvious expedient to provide a suitable chamber for endothelial or epithelial cells in order to provide sufficient length to analyze a tissue response to an agent via an airway tissue model system per Grego's disclosure. This modification would have occurred using known methods and would have yielded highly predictable results to one of ordinary skill in the art at the time the invention was filed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUBA GANESAN whose telephone number is (571)272-3243. The examiner can normally be reached Monday-Friday, 8 AM - 5 PM Mountain Time.
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, Jerrah Edwards can be reached at (408) 918-7557. 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.
/SUBA GANESAN/Primary Examiner, Art Unit 3774
Prosecution Insights