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 .
Response to Applicants Arguments/Amendments
Thank you for amending the claims. The claims have provided clarification of the limitations resulting in examiner withdrawing the former 112(b) rejection. The double patenting rejections remain in place since a terminal disclaimer has not been submitted. Applicants arguments are addressed below each of the rejections with the pertinent references cited in the rejections.
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.
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 32,35-37,50,54,59-60,89-90,93-94 are rejected under 35 U.S.C. 103 as being unpatentable over Turner (US 20110274666) in view of Reid (US 20140301985)
Turner teaches a method of introducing an implant to treat a diseased solid organ (a liver) of a subject, comprising contacting the diseased, impaired, or malfunctioning solid organ with a patch graft to an outer surface of the solid organ (Abstract, Figure 1), wherein the patch graft comprises a mixture of epithelial cells and mesenchymal cells (Paragraph 7), wherein the patch graft comprises a hydrogel supporting the mixture of epithelial cells and mesenchymal cells (Figure 1,Paragraphs 7,10-12), and a backing for attaching the hydrogel to the outer surface of the solid organ, wherein the mixture of epithelial cells and mesenchymal cells is embedded in the hydrogel (Paragraph 5, Figure 1—a backing in the patch structure is up against the organ), The subject treated can be diagnosed with a pathological condition (Paragraph 6).
Turner teaches that the cells are embedded in hydrogel composed of hyaluronans (Paragraph 7). Turner does not teach the migratory ability of such cells embedded in hydrogel to move into a liver organ. However, Example 1 (Paragraphs 104-106) of Reid teaches that graft material composed of cells embedded in hyaluronan could successfully migrate into the liver once placed on a liver. Paragraph 106 in Example 1 of Reid states that the hyaluronan hydrogel localized exclusively to the liver.
It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the hydrogel composed of hyaluronan as taught by Reid. An artisan would have been motivated to have used such a hydrogel because it allows successfully integration of the therapeutic cells into the target organ, the liver (Example 1 of Reid). The backing of the hydrogel allows the cells to migrate into the liver. Such a hydrogel patch promotes migration of the epithelial cells and mesenchymal cells through an outer surface of the solid organ and distribution of at least a portion of the mixture of the epithelial and mesenchymal cells among the cells of the solid organ, such that an introduction, restoration, increase, or improvement of a functionality in the diseased, impaired, or malfunctioning solid organ can be demonstrated. The ability to migrate through the patch allows the epithelial cells and mesenchymal cells to migrate through the outer surface of the solid organ and distribute the cells of the host solid organ such that an alleviation in the treated subject of a negative effect of the disease, impairment, or malfunction of the organ can be demonstrated (Example 1 of Reid) as in instant Claims 32,50, 89, and 90
Turner does not state specifically state that early lineage stage mesenchymal stem cells (ELSMCs) and biliary tree stem cells are used (BTSCs). However, Reid states specifically that biliary tree stem cells (epithelial cells) and angioblasts (a type of early lineage mesenchyme stem cell) can be used (Paragraph 16 of Reid) in a composition designed to regenerate/restore organs. It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used to ELSMCs and BTSCs cells taught by Reid. An artisan would have been motivated to have used the cells taught by Reid because these cell populations form an epithelial-mesenchymal cell partnership that successfully promote repair and regeneration of organs (Abstract and Paragraphs 10 of Reid). Furthermore, Reid discusses above in Example 1 that when the cells are encapsulated in an hyaluronic/hyaluronan hydrogel, there is successfully engraftment into the organ which indicates that the mixture of early lineage stage mesenchymal stem cells and biliary tree stem cells are able to produce matrix metalloproteinases (MMPs) which is capable of breaking down substances such as hyaluronic acid, allowing such cells to migrate into the organ as in instant Claims 32,50,89-90.
Applicants specification teaches that its patch material is composed of hyaluronic acid/hyaluronan. Turner also teaches patch material composed of hyaluronans (Paragraph 7 of Turner) as discussed above. Reid also teaches that early lineage stage mesenchymal stem cells and biliary tree stem cells (a type of epithelial stem cell) can be used (Paragraph 16 of Reid); Reid teaches that such cells can be encapsulated in hyaluronic material (Example 1). Both Turner and Reid teach encapsulating the cells in a hyaluronic medium as recited in the claims. Reid teaches the exact same cell populations as are now recited in the instant claims. Reid even mentions that the cells are able to integrate into the organ (Example 1). The cells mentioned in Reid are inherently able to produce matrix metalloproteinases (MMPs) which allow the cells to break down the surrounding hyaluronan and integrate into the organ.
Dependent Claims taught by Turner
Turner teaches that a graft may be designed for placement on the surface of an organ or tissue and the graft would be held in place with a biocompatible and biodegradable covering (band aid) (Figure 1 and Paragraph 84 of Turner). For some abdominal organs, this covering could be from autologous tissues (Paragraph 84 of Turner). This covering would cover the outside of the hydrogel patch and prevent the patch from adhering to other organs and/or tissues as in instant Claim 35. Turner teaches that the targeted organ could be liver, lung, intestine, kidney, thyroid, thymus, or pancreas (Claim 3) as in instant Claims 36-37 and 54. Turner teaches that a human (a mammal) liver can be treated (Paragraph 67) as in instant Claims 59-60. Turner teaches that the hydrogel contains one or more hyaluronans (Paragraph 7) as in instant Claim 93. Turner teaches wherein the hydrogel has a viscoelasticity from about 10 to 200 pa (Paragraph 12 of Turner) as in instant Claim 94.
Turner teaches a method of implanting mesenchymal and epithelial cells in a subject in need using a patch graft to treat an array of organ conditions and/or dysfunction. Turner does not specifically state that the hyaluronan hydrogel is able to successfully migrate into the organ for treatment. However, Reid teaches a hydrogel graft that allows for successful integration of the cells into the target organ. An artisan would have been motivated to have used the hydrogel graft of Reid since it can successfully distribute the therapeutic cells to the target area of injury. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.'s and Ph.D.'s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cell culture, and graft reconstruction. Therefore, the level of ordinary skill in this art is high.
Response to Applicants Arguments
Applicants argue the following in italics, “ the instant claim have been amended to recite that the first hydrogel is configured to allow the mixture of early lineage stage mesenchymal stem cells (ELSMCs) and biliary tree stem cells (BTSCs) to produce an amount of matrix metalloproteinases (MMPs) in the first hydrogel sufficient to facilitate engraftment of the BTSCs into the solid organ. The cited references, including Turner and Reid, do not mention any role for MMPs in engraftment of cells into the target internal organs. It is only the present application that demonstrated successful engraftment of epithelial stem cells into the internal organs …using a mixed population comprising ELSMCs and BTSCS to produce an amount of MMPs in the first hydrogel sufficient to facilitate engraftment of the BTSCs into the target internal organ.”
This argument is unpersuasive because Reid teaches the precise cells that are now recited in the claims encapsulated in a hyaluronan graft composition used to treat organs. Reid teaches that ELSMC and BTSC cells are capable of moving through hyaluronans to further reach the organ. Turner teaches a hyaluronan patch which is the same type of patch recited in the claims. The cells taught in the Reid reference are the same cells as recited in the claims and these cells are placed in the same environment (hyaluronic encapsulation) as recited in the claims. It would be expected that these cells would produce an amount of metalloproteinase which would allow them to successfully move through the hyaluronan material into the organ; Reid actually teaches this migration into the organ in Example 1. Reid does not expressly state that the migration occurs due to the metalloproteinase produced by the cells; however, metalloproteinase (MMP) production is an inherent property of the cells disclosed in the Reid reference. The instant set of claims do not currently recite additional method steps that would distinguish the claimed invention from the prior art.
Applicants further argue that the Reid reference is not relevant art because, “Reid only refers to injection of cells by endoscopic-medicated (or laparoscopic-mediated) transplantation of stem cells into/onto bile duct wall and does not disclose using a patch graft.” Turner is the primary reference used to teach the hyaluronic patch recited in the instant set of claims. Reid is still relevant as a reference because like Turner it contains hyaluronic graft material that is used deliver encapsulated cells. Reid is also pertinent because it shows that the cells recited in the claims are able to migrate out of the hyaluronic acid material into the organ. Because Reid teaches the same cells as recited in the claims, Reid’s cells also have the ability to produce MMPs which allow for the cells to migrate into an organ as taught in Example 1 of Reid.
Claims 32-33,35-37,46-47,49-51,53-54,59-60,89-94 are rejected under 35 U.S.C. 103 as being unpatentable over Turner (US 20110274666) in view of Reid (US 20140301985) and Sokol (WO 2015028577) and Brown (US 20020159984)
Turner and Reid apply as above to teach claims 32-33,35-37,50,54,59-60,89-90, 93-94. Turner teaches a demonstration comprises measuring in a biological sample obtained from the subject a level of a secretion or metabolic product or effect produced by the therapeutic cells (Paragraph 18 of Turner) as in instant Claims 33,51 and 91-92, Turner teaches that the targeted organ could be liver, lung, intestine, kidney, thyroid, thymus, or pancreas (Claim 3) as in instant Claim 53. Turner teaches that the cells themselves can be assayed for biomarkers (Figure 10 and 12). Turner teaches that the solid organ is a liver (Figure 1) and the secretion of urea can be measured from the mesenchymal and epithelial cells to be transplanted (Paragraphs 24 and 26 and Figures 10-12 of Turner) as in instant Claim 46. Turner teaches that the solid organ is a liver and albumin can be measured (Paragraph 26 and Figure 12) as in instant Claim 47. Turner teaches that alpha-fetal protein can be measured (Paragraph 18 and Figure 12) as in instant Claim 49. Turner teaches in which a demonstration comprises measuring a level of secretion or a metabolic product or effect of the therapeutic epithelial and mesenchymal cells (Figure 4, Paragraph 18, Figure 12) as in instant Claim 51.
Turner does not specifically state that such markers are measured once the therapeutic cells are actually introduced into the body. Sokol teaches that such therapeutic cells can be studied by assessing the biomarkers in an in-vitro setting or in-vivo setting once the cells are introduced into a recipient (Paragraphs 121-122). The biomarkers can be used to determine the functionality of the therapeutic cells (Paragraph 121-122). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have studied the markers in an in-vivo setting. An artisan would have been motivated to study the biomarkers once the cells were introduced into the body in order to study how the implant, organ, and/or body responded after the graft patch was given to a subject (Paragraphs 121-122 of Sokol). There would be a high expectation of success since assessing the effectiveness of an in-vivo therapy by studying the effects and biomarkers is known (Paragraphs 121-122 of Sokol) as in instant Claims 33.
Sokol teaches measuring the levels after the implantation/transplantation. Sokol does not teach that monitoring should start before implantation/transplantation. Brown teaches that monitoring can occur before, during, and after implantation. It would have been obvious to an artisan of ordinary skill in the art to have performed monitoring before, during, or after implantation. An artisan would have been motivated to have monitored the subject before, during, or after implantation in order to be able to assess how implantation affected a subject (Claim 5). Because Brown teaches that such monitoring is available, there would have been a high expectation for success as in instant Claims 33.
Dependent Claims taught by Sokol
Sokol teaches measuring in a biological sample obtained from the subject a level of secretion or metabolic product or effect. Biomarkers can be secreted, they can be considered an effect of the cells, and they constitute a metabolic product (Sokol Paragraphs 38, 121-122) as in instant Claim 33. The solid organ comprises an endoderm organ/liver (abstract) as in instant Claim 36,37,46. Sokol teaches that reduced bilirubin levels can be measured (Paragraph 9 of Sokol) as in instant Claim 46. Paragraph 99 of Sokol discusses detecting the activity level/reduced activity levels of liver specific metabolic activities such as albumin, bile production, urea, and cholesterol synthesis as in instant Claim 47.
Turner teaches a method of implanting mesenchymal and epithelial cells using a patch graft to treat an array of organ conditions and/or dysfunction. Turner does not expressly state that the hyaluronan hydrogel is able to successfully migrate into the organ for treatment. However, Reid teaches a hydrogel graft that allows for successful integration of the cells into the target organ (Example 1 Reid). An artisan would have been motivated to have used the hydrogel graft of Reid since it can successfully distribute the therapeutic cells to the target area of injury (Example 1 of Reid). Sokol teaches that measurements of biomarkers and effects can be carried out in-vivo to assess the organ, the therapeutic cells, and the subject receiving the implant. Brown teaches that monitoring can occur before, during, or after implantation (Claim 5 of Brown). An artisan would have been motivated to have tested a subject at such time points to assess the success of an implantation. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.'s and Ph.D.'s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cell culture, and graft reconstruction. Therefore, the level of ordinary skill in this art is high.
Response to Applicants Arguments
Applicants argue that Sokal is not relevant art because it refers to the use of a sponge or other 3D structures to growth and differentiate cells in vitro. Sokal still teaches the monitoring of implant material and thus it is still relevant art. Furthermore, Sokol states that biomarker monitoring can be carried out “either in vivo or in vitro” (Paragraph 121 of Sokol). Sokol does not need to teach a patch graft for engrafting a mixture of ELSMCs and BTSCs in hydrogel because these limitations are already taught by Turner and Reid.
Claim 32-33,35-37,46-51,53-54,59-60,89-94 are rejected under 35 U.S.C. 103 as being unpatentable over Turner (US 20110274666) in view of Reid (US 20140301985), Sokol (WO 2015028577), Brown (US 20020159984), and Hickey “Noninvasive 3D imaging of liver regeneration in a mouse model of heredity tyrosinemia type 1 using sodium iodide symporter gene” Liver Transpl 2015, April 21(4): 442-453.
Turner, Reid, Sokol, and Brown apply as above to teach claims 32-33,35-37,46-47,49-51,53-54,59-60,89-94. Paragraph 135 of Sokol mention that its patch composition can be used to treat Tyrosinemia. Neither Turner, Reid, or Sokol state that the Tyrosinemia is Type 1. Hikey teaches that Tyrosinemia type 1 can be cured by transplanting cells. It would have been obvious to an artisan of ordinary skill in the art to have used the therapeutic cells taught by Turner to treat Tyrosinemia Type 1. An artisan would have been motivated to have used the cells of Turner to treat Tyrosinemia Type 1 because it is known that cell transplantation is useful for repopulating a diseased liver and the transplanted cells would help to provide a functional enzyme for tyrosine metabolism that is diminished or non-functional in patients with Tyrosinemia Type 1 (Hickey, Page 2, last paragraph). The cells transplanted in Hickey are the same types of cells that are used in the Sokol/Turner reference. Since such cells are able to engraft onto the diseased liver, there would be a high expectation for success as in instant Claim 48.
Dependent Claims taught by Hickey
Hickey teaches that liver regeneration and/or alleviation by transplanted cells can be visualized using a 3D imaging demonstration (Abstract; Intro Section). An artisan would have been motivated to have used the non-invasive NIS 3D imagining method of Hickey with the method taught in Turner because as explained in Hickey, the 3D detection system provides a method of monitoring the cells noninvasively and longitudinally after introduction in the body (Page 2). The 3D imaging system for Hickey provides “both qualitative and quantitative analysis of the cells (Introduction Statement).” Because this technique works for cell visualization, there would be a high expectation for success as in instant Claims 34 and 50-51. The solid organ is an endodermal organ/liver (Paragraph 127) as in instant Claims 53- 54. The subject comprises a mammal (Paragraph 126) as in instant Claim 59. The mammal is a human (Paragraph 126) as in instant Claim 60.
Turner teaches a method of implanting mesenchymal and epithelial cells using a patch graft to treat an array of organ conditions and/or dysfunction. Turner does not expressly state that the hyaluronan hydrogel is able to successfully migrate into the organ for treatment. However, Reid teaches a hydrogel graft that allows for successful integration of the cells into the target organ (Example 1 Reid). An artisan would have been motivated to have used the hydrogel graft of Reid since it can successfully distribute the therapeutic cells to the target area of injury (Example 1 of Reid). Sokol teaches that measurements of biomarkers and effects can be carried out in-vivo to assess the organ, the therapeutic cells, and the subject receiving the implant. Hickey teaches that such cells can be used to treat individuals who suffer from type 1 tyrosinemia. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.'s and Ph.D.'s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cell culture, and graft reconstruction. Therefore, the level of ordinary skill in this art is high.
Response to Arguments Against Hickey
Applicants argue that Hickey is defective because it fails to cure the deficiencies of Sokol, Turner, and Reid. Because these reference are not deficient, Hickey is not defective.
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 32,50,89-90,93-94 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4-5,8-16 of U.S. Patent No. 11,129,923. Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set now describes graft/patch entities with hydrogels containing a combination of mesenchymal and epithelial cells. The patch contains a backing which propels the cells forward into the target organ. The limitations of instant claims 32,50,89-90 correspond with claims 1 and 8-10 of Patent 11,129,923 since the claims describe a patch with a hydrogel capable of supporting a population of mesenchymal and epithelial cells. Both sets of claims describes a backing on the patch component. Claims 9-16 of Patent 11,129,923 further describe the mesenchymal/epithelial cells present. Claim 4 of 11,129,923 corresponds to instant claim 93. Claims 1 and 5 of 11,129,923 corresponds to instant claim 94.
Claims 32,50,89-90,93-94 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4,8-12,21-22 of U.S. Patent No. 11,738,117. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of patent 11,738,117 (claims 1,8-12) disclose a hydrogel patch containing early lineage stage mesenchymal stem cells and biliary tree stem cells as recited in the instant independent claims. Furthermore, instant claim 93 corresponds to claim 4 of Patent 11,738,117. Instant claim 94 corresponds to claims 21-22 of Patent 11,738,117.
Claims 32,50,89-90,93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,6,10-14 of copending Application No. 18,239,036 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1,10-14 of Application 18,239,036 disclose a hydrogel patch containing early lineage stage mesenchymal stem cells and biliary tree stem cells which correspond to the limitations recited in the instant independent claims. Furthermore, instant claim 93 corresponds to claim 6 of Application 18,239,036. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 32,36-37,50,53-54,89,90,93-94 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1,3,15,21 of copending Application No. 16/006,460 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims 32,50,89,90 describe a patch with a backing containing a hydrogel with BTSCs and ELSMCs present. These claim limitations are present in claim 1 and 19 of application 16/006,460. The specific mesenchymal and epithelial cells utilized in application 16/006,460 are further described in claim 21. Claim 3 of 16/006,460 corresponds to instant claims 36-37 and 53-54. Claim 15 of 16/006,460 corresponds to instant claim 93. The limitations present in instant claim 94 are recited in claim 1 of 16/006,460. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 32,50,89,90,93-94 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,10-18 of copending Application No. 16/006,482 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims teach a patch with a backing containing a hydrogel which supports mesenchymal and epithelial cells. Claims 1 and 10 of Application 16/006,482 teach the limitations found in instant Claims 32,50,89,90. Claims 11-18 of 16/006,482 teach the different types of mesenchymal and epithelial cells which can be used. The limitation recited in instant claim 93 is present in claim 6 of Application 16/006,482 The limitation recited in instant Claim 94 is present in claim 1 of 16/006,482. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 32,50,89-90,93-94 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26,30,34-37,44 of copending Application 17/867,135. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims teach a patch with a backing containing a hydrogel which supports mesenchymal (ELSMCs) and epithelial cells (BTSCs) which can be used in a treatment such as being incorporated into the liver. Claims 26 and 34-37 of 17/867,135 teach the limitations present in instant claims 32,50,89, and 90. Claim 30 of 17/867,135 corresponds to instant claim 93. Claim 44 of 17/867,135 corresponds to instant claim 94.
Conclusion
All claims stand rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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, Tracy Vivlemore can be reached at 571-272-2914. 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.
LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638