DETAILED ACTION
Claim Status
As of the Non-Final Office Action mailed 4/7/2026, claims 1-14 were pending.
In Applicant's Response filed on 8/7/2026, claims 1-2, 5, 8, and 12 were amended, claims 15-21 were added, and claim 14 was canceled.
As such, claims 1-13 and 15-21 are pending and have been examined herein.
Withdrawn Objections/Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections or rejections not specifically reiterated are hereby withdrawn.
The objection of record to claim 1 for minor informalities has been withdrawn in view of Applicant’s amendments.
The rejection of record of claim 5-7 and 8-11 under 35 USC § 112(b) have been withdrawn in view of Applicant’s amendment to claim 5 and 8. The rejection of claim 14 is moot in view of its cancelation.
The rejection of record of claim 12 under 35 USC § 101 as being directed to a product of nature has been withdrawn in view of Applicant’s amendments.
The rejection of record of claim 14 under 35 USC § 101 as being directed to an abstract idea is moot in view of its cancelation.
The rejection of record of claim 12 under 35 USC § 102(a)(1) as being anticipated by Fischer et al (of record) has been withdrawn in view of Applicant’s amendments to claim 12.
Claim Rejections - 35 USC § 103 - Modified
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-13 and 15-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsusaki et al (US 20180355308 A1, filed 8/20/2018; published 12/13/2018; of record) in view of Matsusaki et al (WO2018143286 A1, filed 1/31/2018; published 8/9/2018; of record; referenced herein as “Shinji” for clarity of record). Please note that this rejection has been modified to address amendment to the previously pending claims and newly added claims 15-21.
Regarding claim 1, Matsusaki teaches a method for producing a three-dimensional tissue comprising mixing cells with a cationic substance and an extracellular matrix component to obtain a mixture, gathering the cells from the mixture to form a cell aggregate on the substrate and culturing the cells to obtain a three-dimensional cell tissue (see claim 1 of Matsusaki).
Regarding claim 2 and 15, Matsusaki teaches that the cells can comprise one or more types of cells selected from the group consisting of vascular endothelial cells, cancer cells, cardiomyocytes, smooth muscle cells, and epithelial cells. (see claim 15 of Matsusaki)
Regarding claim 5, Matsusaki teaches that the cells are further mixed with a polymeric electrolyte (see claim 2 of Matsusaki).
Regarding claims 6 and 13, Matsusaki teaches that the polymeric electrolyte is selected from the group consisting of glycosaminoglycan, dextran sulfate, rhamnan sulfate, fucoidan, carrageenan, polystyrene sulfonic acid, polyacrylamide-2-methylpropanesulfonic acid, polyacrylic acid, and a combination thereof (see claim 8 of Matsusaki; para 0079).
Regarding claim 7, Matsusaki teaches that the concentration of the polyelectrolyte is 0.05 mg/mL or more (see claim 11 of Matsusaki).
Regarding claim 8, Matsusaki teaches that the extracellular matrix component may be used alone, or may be used in combination (para 0079).
Regarding claim 9 and 17-18, Matsusaki teaches that the extracellular matrix component is selected from the group consisting of collagen, laminin, fibronectin, vitronectin, elastin, tenascin, entactin, fibrillin, proteoglycan, and a combination thereof (see claim 9 of Matsusaki).
Regarding claim 11, Matsusaki teaches that the concentration of the extracellular matrix component used in the present embodiment is preferably more than 0 mg/mL and less than 1.0 mg/mL (para 80).
Regarding claim 12, Matsusaki teaches a three-dimensional cell tissue comprising cells, an extracellular matrix component, and a polymeric electrolyte (see claims 24-25 of Matsusaki).
Regarding claim 16, example 10 of Matsusaki discusses using TRIS as a cationic substance (para 143 of Matsusaki). The tissue constructed by using tris and an extracellular matrix component and the tissue constructed by using tris, a polymeric electrolyte, and an extracellular matrix component had almost no voids inside and were significantly favorable three-dimensional cell tissues (para 158).
Regarding claim 20, Matsusaki teaches that in a case where a concentration of heparin was 1.0 mg/mL or more and a concentration of collagen was 1.0 mg/mL or more, formation of aggregation of collagen and contraction of a tissue were observed (para 100). From the result, it was shown that, in a case of using NHDF, both of the concentration of heparin and the concentration of collagen were preferably more than 0 mg/mL and less than 1.0 mg/mL (same para).
Matsusaki does not teach:
that the initial ECM added is a fragmented ECM.
Regarding (i), Shinji teaches a three-dimensional tissue body comprising cells and collagen, and fragmented collagen (see abstract and claims of Shinji) (pertinent to instant claims 1 in-part, 12 in-part, and 3).
Shinji continues to teach that by utilizing fragmented collagen, the cells contact and adhere to the fragmented collagen. Thereafter, the cells themselves produce proteins that constitute the extracellular matrix (ECM) (e.g., collagen such as fibrous collagen) (Methods for producing, para 7). The produced protein contacts and adheres to the fragmented collagen, thereby functioning as a cross-linking agent between the fragmented collagens, and the structuring of fibrous collagen and the like proceeds in an environment where cells exist uniformly (same para). As a result, a three-dimensional tissue body that is more stable and in which cells are uniformly distributed is obtained (same para).
Shinji continues to teach that the thickness of the three-dimensional structure is preferably 10 μm or more, more preferably 100 μm or more, and even more preferably 1000 μm or more (“Preparation” para 7).
Regarding claim 20, of Shinji teaches that on the NHDF collagen gel, the medium in the insert is aspirated and coated with a 0.04 mg / mL collagen IV (para 3 of working example 11).
Regarding claim 21, Shinji teaches wherein an average length of the fragmented collagen is 100 nm to 200 µm and has an average diameter of 50 nm to 30 µm (see claims of Shinji).
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to create a three-dimensional tissue body using ECM, cells, and a cationic substance as taught by Matsusaki, where the ECM is fragmented as taught by Shinji, to arrive at the instantly claimed invention. Shinji shows that a three-dimensional tissue body can be created using fragmented collagen. One of ordinary skill would have been motivated to simply substitute one known element [first ECM of Matsusaki] for another [fragmented collagen of Shinji] to obtain the predictable result of advantageously producing a three-dimensional tissue body that has cells that are uniformly distributed as taught by the prior art.
Regarding instant claim 4, Shinji does not explicitly state that the fragmented collagen is defibrated. However, the reference teaches that the collagen is fragmented using a homogenizer such as an ultrasonic homogenizer, stirring homogenizer, or a high-pressure homogenizer. The collagen can be homogenized in an aqueous medium such as physiological saline. The examiner notes that Applicant’s instant specification describes defibration of extracellular matrix through “application of physical force with an ultrasonic homogenizer, a stirring homogenizer, a high-pressure homogenizer, and the like, for example. In a case of using a stirring homogenizer, extracellular matrix components may be homogenized as they are or may be homogenized in an aqueous medium such as physiological saline.” (see para 50 of the instant specification. Thus, absent evidence to the contrary, the fragmented collagen of Shinji is defibrated collagen as instantly claimed.
Regarding claim 10, neither reference teaches that a mass ratio of the ECM to fragmented ECM is 2:1 to 1:50. However, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions µof 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 MPEP 2144.05(II)(A)).
Response to Arguments
Applicant’s arguments and the Declaration by Dr. Michiya Matsusaki (“Matsusaki Declaration”) have been fully considered but have not been found persuasive.
On p. 6-9 of Remarks, Applicant argues that the Matsusaki Declaration shows that the 3D tissue body of example 1 (containing NHDF, HUVEC, collagen, fragmented collagen, TRIS, and heparin) maintained a thickness of 80 to 200 µm and high VEGF-A after 72 hours. Applicant argues that a comparison between this example and a Matsusaki-like system or Shinji-like system shows retention rates of only 45% and 51%. Applicant argues, in sum, that the unexpected result is due to the presence of fragmented collagen and heparin in the instantly claimed composition. Specifically, regarding the fragmented collagen, Applicant argues that the fragmented collagen molecules establish tighter and more stable cell-to-cell adhesion networks and fills microscopic gaps between cells to mimic native tissue. Applicant argues that heparin as the polyelectrolyte effectively prevents localized aggregation of collagen and ensures “highly homogenized, evenly distributed matrix network throughout the tissue”.
While Applicant’s arguments have been fully considered, they are not persuasive. Applicant argues that the method of Matsusaki and Shinji, in their individual capacity, show inferior results to Applicant’s instantly claimed invention. However, obviousness is shown both by what the prior art references teach individually and in combination. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). While neither reference explicitly state that high VEGF-A retention rate, regarding the use of heparin, Matsusaki explicitly teaches “a mixture of cells, heparin, and collagen into a culture container, by obtaining a viscous body from the mixture, and using the viscous body, it was possible to obtain a more homogeneous three-dimensional cell tissue” (para 107). Regarding the use of fragmented collagen, Shinji explicitly teaches that the invention described therein has a fibrous collagen concentration close to that of living tissue (see Shinji disclosure). The three-dimensional tissue according to the present embodiment has a higher collagen concentration than the conventional one, and is less susceptible to contraction and stable (“Three dimensional organization” para 1). Moreover, Shinji states “In the conventional method for producing a three-dimensional tissue body using a scaffold, it is difficult to uniformly distribute cells to the inside of the scaffold because target cells are injected into a prepared scaffold. According to the manufacturing method according to the present embodiment, the obtained three-dimensional tissue is stable and cells are uniformly distributed. Details of the mechanism by which such a three-dimensional structure is obtained are unknown, but are presumed as follows. First, the cells contact and adhere to the fragmented collagen. Thereafter, the cells themselves produce proteins that constitute the extracellular matrix (ECM) (eg, collagen such as fibrous collagen). The produced protein contacts and adheres to the fragmented collagen, thereby functioning as a cross-linking agent between the fragmented collagens, and the structuring of fibrous collagen and the like proceeds in an environment where cells exist uniformly. As a result, a three-dimensional tissue body that is more stable and in which cells are uniformly distributed is obtained” (“Method for producing a three-dimensional structure” para 6). The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Furthermore, it is prima facie obvious to combine two compositions or methods, each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition or method to be used for the very same purpose. Thus, Applicant’s arguments are not persuasive.
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 1-9 and 11-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6, and 12 of U.S. Patent No. US 11,179,495 B2 in view of Matsusaki et al (US20180355308 A1, 8/20/2018; published 12/13/2018).
Claim 1 of ‘495 recites “A three-dimensional tissue constructed ex vivo, comprising: cells; and
collagen, wherein the collagen includes: endogenous collagen, and a plurality of fragmented collagen pieces fragmented from each other in fragmented form derived from exogenous collagen, at least a portion of the cells is adhered to the collagen, a content of the collagen is 10 wt % to 90 wt % based on weight of the three-dimensional tissue, the plurality of fragmented collagen pieces are uniformly distributed among the cells, three-dimensionally throughout the three-dimensional tissue, the cells and the plurality of fragmented collagen pieces in the fragmented form are in contact, respectively, and an average length of the fragmented collagen pieces is from 100 nm to 200 μm”, which reads on “A three-dimensional tissue body comprising: cells; a fragmented extracellular matrix component” as in instant claim 12 in-part.
Claim 6 of ‘495 recites “A three-dimensional tissue constructed ex vivo, comprising: cells; and
collagen, wherein the collagen includes: endogenous collagen, and a plurality of fragmented collagen pieces fragmented from each other in fragmented form derived from exogenous collagen, at least a portion of the cells is adhered to the collagen, a content of the collagen is 10 wt % to 90 wt % based on weight of the three-dimensional tissue, the plurality of fragmented collagen pieces are uniformly distributed among the cells, three-dimensionally throughout the three-dimensional tissue, the cells and the plurality of fragmented collagen pieces in the fragmented form are in contact, respectively, and an average diameter of the fragmented collagen pieces is from 50 nm to 30 μm”, which reads on “A three-dimensional tissue body comprising: cells; a fragmented extracellular matrix component” as in instant claim 12 in-part.
Claim 12 of ‘495 recites “A method for producing a three-dimensional tissue, comprising:
bringing cells suspended in an aqueous medium into contact with a plurality of fragmented collagen pieces derived from exogenous collagen in the aqueous medium;” (i.e., mixing cells with fragmented extracellular matrix), “concentrating, from the aqueous medium, the cells brought into contact with the plurality of fragmented collagen pieces and the plurality of fragmented collagen pieces together; and after the concentrating, culturing the cells brought into contact with the fragmented collagen pieces, with the plurality of fragmented collagen pieces”, which reads on “A method for producing a three-dimensional tissue body, comprising: a step of obtaining a mixture by mixing . . . a fragmented extracellular matrix component with cells; and a step of culturing the cells after the step of obtaining the mixture” as in instant claim 1 in-part, “wherein the fragmented extracellular matrix component comprises fragmented collagen” as in instant claim 3 and instant claim 4.
Claim 2 of ‘495 recites “wherein the cells comprise a collagen-producing cell” and claim 5 of ‘495 recites “wherein the cells comprise one or more types of cells selected from the group consisting of vascular endothelial cells”, which reads on “wherein the cells comprise at least interstitial cells and endothelial cells.” as in instant claim 2.
‘495 does not state that the three-dimensional tissue body comprises a polyelectrolyte nor mixing a cationic substance to create the three dimensional tissue.
However, Matsusaki teaches a three dimensional tissue comprising cell, extracellular matrix component and further comprising a polymeric electrolyte (see claim 24 of Matsusaki). It also shows that a three-dimensional cell tissue can be created by a step A of mixing cells with a cationic substance and an extracellular matrix component to obtain a mixture; a step B of gathering the cells from the obtained mixture to form a cell aggregate on a substrate; and a step C of culturing the cells to obtain a three-dimensional cell tissue (see claim 1 of Matsusaki). The reference teaches that the cells are further mixed with a polymeric electrolyte (see claim 2 of Matsusaki) (“wherein, when obtaining the mixture, a polyelectrolyte is furthermore mixed with the cells in addition to the cationic substance and the fragmented extracellular matrix to incorporate the polyelectrolyte into the mixture” as in instant claim 5). The polymeric electrolyte is selected from the group consisting of glycosaminoglycan, dextran sulfate, rhamnan sulfate, fucoidan, carrageenan, polystyrene sulfonic acid, polyacrylamide-2-methylpropanesulfonic acid, polyacrylic acid, and a combination thereof (see claim 8 of Matsusaki) (“wherein the polyelectrolyte comprises at least one selected from the group consisting of glycosaminoglycan, dextran sulfate, rhamnan sulfate, fucoidan, carrageenan, polystyrene sulfonic acid, polyacrylamide-2-methylpropanesulfonic acid, and polyacrylic acid” as in instant claim 6 and instant claim 13). The extracellular matrix component is selected from the group consisting of collagen, laminin, fibronectin, vitronectin, elastin, tenascin, entactin, fibrillin, proteoglycan, and a combination thereof (see claim 9 of Matsusaki). The concentration of the polyelectrolyte is 0.05 mg/mL or more (see claim 11 of Matsusaki) (“wherein a concentration of the polyelectrolyte in the mixture is higher than 0 mg/mL and lower than or equal to 1.5 mg/mL” as in instant claim 7). The extracellular matrix component may be used alone, or may be used in combination (para 0079) (“wherein, when obtaining the mixture, an extracellular matrix component is furthermore mixed with the cells simultaneously or separately with respect to the cationic substance” as in instant claim 8; “the extracellular matrix component comprises at least one selected from the group consisting of collagen, laminin, fibronectin, vitronectin, elastin, tenascin, entactin, fibrillin, and proteoglycan” as in instant claim 9). It also teaches a three-dimensional cell tissue comprising cells, an extracellular matrix component, and a polymeric electrolyte (see claims 24-25 of Matsusaki) (“A three-dimensional tissue body comprising: cells; a . . . extracellular matrix component; and a polyelectrolyte.” as in instant claim 12 in-part). The cells can be vascular endothelial cells (see claim 15 of Matsusaki). The concentration of the extracellular matrix component used in the present embodiment is preferably more than 0 mg/mL and less than 1.0 mg/mL (para 80) (“wherein a total content of the extracellular matrix component . . . is 0.005 mg/mL to 1.5 mg/mL” as in instant claim 11). By mixing cells with a cationic substance, a polymeric electrolyte, and an extracellular matrix component, a thicker three-dimensional cell tissue can be created (i.e., retain thickness as in instant claim 14).
Therefore, it would have been obvious to modify the ‘495 claims with the cationic substance and polyelectrolyte of the Matsusaki reference to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make the modification because Matsusaki teaches that having a cationic substance with the other ingredients advantageously creates thicker three-dimensional tissues.
Claims 1-3, 5-7, 9, and 11 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 8-9, 11-12, and 31 of copending Application No. 16/105625 (referenced herein as ‘625) in view of WO2018143286 A1 (referenced herein as “Shinji”).
Claim 1 of ‘625 recites “method of producing a three-dimensional cell tissue, comprising: preparing a mixture solution of a cationic substance, an extracellular matrix component, and a polymeric electrolyte; mixing cells with the mixture solution, to obtain a mixture as a liquid including the cells, the cationic substance, the extracellular matrix component, and the polymeric electrolyte; removing at least a portion of the liquid from the mixture to obtain an aggregate of the cells from the mixture; suspending the aggregate of the cells in a solution to obtain a suspension; precipitating the aggregate of the cells from the suspension to obtain cell precipitates on a substrate, the cell precipitates being stackable as a plurality of layers of cell precipitates based on repeating of the mixing, the removing, the suspending and the precipitating to construct a three- dimensional tissue; and culturing the cell precipitates to obtain the three-dimensional cell tissue.” which reads on “method for producing a three-dimensional tissue body, comprising: a step of obtaining a mixture by mixing a cationic substance and a . . . extracellular matrix component with cells; and a step of culturing the cells after the step of obtaining the mixture.” as in instant claim 1 and “when obtaining the mixture, a polyelectrolyte is furthermore mixed with the cells in addition to the cationic substance and the fragmented extracellular matrix to incorporate the polyelectrolyte into the mixture” as in instant claim 5.
Claim 8 of ‘625 recites “wherein the polymeric electrolyte includes an electrolyte selected from a group consisting of glycosaminoglycan, dextran sulfate, rharnan sulfate, fucoidan, carrageenan, polystyrene sulfonic acid, polyacrylamide-2-methylpropanesulfonic acid, polyacrylic acid, and a combination thereof” which reads on “wherein the polyelectrolyte comprises at least one selected from the group consisting of glycosaminoglycan, dextran sulfate, rhamnan sulfate, fucoidan, carrageenan, polystyrene sulfonic acid, polyacrylamide-2-methylpropanesulfonic acid, and polyacrylic acid.” as in instant claim 6.
Claim 9 of ‘625 recites “wherein the extracellular matrix component includes a component selected from a group consisting of collagen, laminin, fibronectin, vitronectin, elastin, tenascin, entactin, fibrillin, proteoglycan, and a combination thereof” and claim 31 of ‘625 recites “wherein the extracellular matrix component is Collagen I or Collagen II and the polymeric electrolyte is selected from the group consisting of glycosaminoglycan, dextran sulfate, polystyrene sulfonic acid, and a combination thereof” which reads on “wherein the extracellular matrix component comprises at least one selected from the group consisting of collagen, laminin, fibronectin, vitronectin, elastin, tenascin, entactin, fibrillin, and proteoglycan” as in instant claim 9.
Claim 11 of ‘625 recites “wherein a concentration of the polymeric electrolyte is 0.05 mg/mL or more to 0.1 mg/mL or less” which reads on “wherein a concentration of the polyelectrolyte in the mixture is higher than 0 mg/mL and lower than or equal to 1.5 mg/mL” as in instant claim 7.
Claim 12 of ‘625 recites “wherein a concentration of the extracellular matrix component is from 0.05 mg/mL or more to 0.1 mg/mL or less” which overlaps with “wherein a total content of the extracellular matrix component and the fragmented extracellular matrix component in the mixture is 0.005 mg/mL to 1.5 mg/mL” as in instant claim 11 in-part.
‘625 does not state that the ECM component is a fragmented ECM.
However, Shinji teaches a three-dimensional tissue body comprising cells and collagen, and fragmented collagen (see abstract and claims of Shinji) (“a fragmented extracellular matrix component with cells” as in instant claim 1 in-part; “wherein the fragmented extracellular matrix component comprises fragmented collagen” as in instant claim 3). The reference teaches that by utilizing fragmented collagen, the cells contact and adhere to the fragmented collagen. Thereafter, the cells themselves produce proteins that constitute the extracellular matrix (ECM) (e.g., collagen such as fibrous collagen). The produced protein contacts and adheres to the fragmented collagen, thereby functioning as a cross-linking agent between the fragmented collagens, and the structuring of fibrous collagen and the like proceeds in an environment where cells exist uniformly. As a result, a three-dimensional tissue body that is more stable and in which cells are uniformly distributed is obtained. Collagen-producing cells can be used in the tissue body (i.e., interstitial cells) (“interstitial cells” as in instant claim 2 in-part).
Therefore, it would have been obvious to modify the ‘625 claims with the fragmented ECM of the Shinji reference to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make the modification because Shinji teaches that a three-dimensional tissue body that is more stable and in which cells are uniformly distributed is obtained.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments have been fully considered but have not been found persuasive.
On p. 10 of Remarks, Applicant states that they are deferring responding to these rejections until the examiner indicates the application is in condition for allowance.
While Applicant’s arguments have been fully considered, they are not persuasive. The examiner is interpreting that Applicant wishes these rejections to be held in abeyance. In response, double patenting rejections cannot be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Therefore, an application must not be allowed unless the required compliant terminal disclaimer is filed and/or the withdrawal of the nonstatutory double patenting rejection is made of record by the examiner. See MPEP 804.02(IV) for filing terminal disclaimers required to overcome nonstatutory double patenting rejections in applications filed on or after June 8, 1995). Thus, the rejections have been maintained.
Conclusion
No claim is allowed.
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.
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/G.R./Examiner, Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
