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 .
DETAILED ACTION
Claim Status
This action is in response to the claims filed on 11/14/2024.
Claims 1-6 are pending and are considered on the merits.
Priority
This application claims benefit from foreign application JP2023-195291 (filed on 11/16/2023). The priority claim of the instant application has been granted and the earliest benefit date is 11/16/2023 from the application JP2023-195291.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/14/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The corresponding signed and initialed PTO form 1449 has been mailed with this action.
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 1-5 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Kasuya et al., (Tissue Eng Part A. 2011;17(3-4):361-370).
Kasuya teaches a three-dimensional triculture model of a liver functional unit comprising hepatocyte and hepatic stellate cells (HSCs) using a microporous membrane (see e.g., abstract and p. 362, right col, section “Triculture of SHs, HSCs, and ECs”), thus teaches the preamble a cell culture membrane (i.e., the microporous membrane) capable of culturing a hepatic stellate cell in claim 1, and the preamble of an organ imitation structure (i.e., a liver functional unit) in claims 4 and 5.
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Kasuya teaches the microporous membrane comprises a membrane body (e.g., see Fig 4B SEM imaging attached) having a first face and a second face located on a side opposite to the first face (see attached Fig 4B); and a plurality of holes provided in the membrane body (see attached Fig 4B). Kasuya teaches the holes have a mortar shape (see attached modified Fig 4B traced in panels 2-4) and the holes are open to at least the first face in claim 1 and are through holes penetrating from the first face to the second face in claim 3 (see attached Fig 4B). Kasuya teaches one of the average hole diameters (i.e., the pore sizes) is 8.0 µm (see e.g., p. 362, right col, section “Triculture of SHs, HSCs, and ECs” and see Fig 3A-3B far right panels for 8.0 µm), thus teaches a first average hole diameter of the plurality of holes at the first face is 4 µm or more and 13 µm or less in claim 1 and is 6 µm or more and 10 µm or less in claim 2.
Kasuya teaches the triculture model of a liver functional unit (i.e., an organ imitation structure) comprises the cell culture membrane and the hepatic stellate cell cultured on the first face (see HSC on the first face in the attached Fig 4B) in claims 4 and 5, and further comprises a hepatocyte cultured on the second face in claim 5.
Accordingly, Kasuya anticipates instant claims 1-5.
Claim 6 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Salerno et al., (Biomaterials. 2009; 30: 4348-4356) as evidenced by Kamm et al., (J Physiol. 2022 March; 600.8: 1825-1837).
Salerno teaches culturing human hepatocytes on PEEK-WC–PU membranes (e.g., abstract. It is noted that “PU” stands for polyurethane, see p. 4348, last para.), thus teaches a cell culture membrane comprising polyurethane.
In regard to the cell culture membrane capable of culturing a hepatic stellate cell, Salerno teaches the purity of isolated hepatocytes is 95% and nonparenchymal cells are present in 5% (p. 4349, right col, section 2.3 “human hepatocytes culture”), and teaches nonparenchymal cells, such as CK19 positive cells (i.e., biliary duct epithelium), are found on the membranes (e.g., abstract and Fig 4). Thus, Salerno teaches the cell culture membrane is capable of culturing nonparenchymal cells.
Kamm evidences that hepatic stellate cells are non-parenchymal cells and comprise between 5% and 10% of all resident cells within the liver, or from as little as 0.3% up to ∼15% of isolated liver cells (p. 1826, left col, “Introduction”), thus evidences that Salerno’s isolated nonparenchymal cells from liver comprise hepatic stellate cells, and accordingly, Salerno’s cell culture membrane is capable of culturing a hepatic stellate cell.
In regard to the limitation when the hepatic stellate cell is cultured on the cell culture membrane, a deactivated state of the hepatic stellate cell is maintained for one week or more, as a first matter, it is noted that this wherein clause is directed to a contingent limitation based on the condition that the hepatic stellate cell is cultured on the cell culture membrane, and does not limit the structure of the claimed cell culture membrane. Thus, the wherein clause does not provide any patentable weight in determining patentability of the claimed product. See MPEP 2111.04 II.
Furthermore, it is noted that this limitation is directed to an intrinsic property of the claimed cell culture membrane (i.e., that is capable of maintaining the hepatic stellate cell in a deactivated state for one week or more). MPEP 2145 (II) states that “mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention”, and “the fact that appellant 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.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”. In instant case, since the cell culture membrane comprising polyurethane taught by Salerno evidenced by Kamm is the same as the instantly claimed cell culture membrane comprising polyurethane, mere recognition of latent properties, being capable of maintaining the hepatic stellate cell in a deactivated state for one week or more, of the cell culture membrane of prior art cannot be the basis for patentability.
Accordingly, Salerno, evidenced by Kamm, anticipates instant claim 6.
Double Patenting Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over copending claims 1-2 of US Patent No. 10,415,009 (‘009). Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent claims recite a cell culture device comprising a cell culture membrane, wherein the cell culture membrane is made from a thermosetting resin and has a plurality of pores that are open to at least one surface, the thermosetting resin from which the cell culture membrane is made is polyurethane, related to instant claim 6. It is noted that the limitations “capable of culturing a hepatic stellate cell” and “when the hepatic stellate cell is cultured on the cell culture membrane” in instant claim 6 are directed to an intrinsic inherent property of the claimed cell culture membrane and to contingent limitation that do not limit the structure of the claimed cell culture membrane. See MPEP 2145 (II) and MPEP 2111.04 II.
The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited patent claims, said claims are not patentably distinct.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of US Patent No. 9,637,722 (‘722). Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent claims recite a production method of a polyurethane porous membrane to be used for at least one of applications of cell culture, related to a polyurethane cell culture membrane of instant claim 6. It is noted that the limitations “capable of culturing a hepatic stellate cell” and “when the hepatic stellate cell is cultured on the cell culture membrane” in instant claim 6 are directed to an intrinsic inherent property of the claimed cell culture membrane and contingent limitation that do not limit the structure of the claimed cell culture membrane. See MPEP 2145 (II) and MPEP 2111.04 II.
One of ordinary skill in the art would have immediately expected that claimed production method in the US patent would have resulted in the production of a polyurethane cell culture membrane of instant claim 6.
Since the instant application claim is made obvious over the cited patent claims, said claims are not patentably distinct.
Provisional Double Patenting Rejections
Claims 1-3 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending claims of copending Application No. 18/930,711 (‘711) and 18/928,894 (‘894). Although the claims at issue are not identical, they are not patentably distinct from each other.
Copending claims of ‘711 and ‘894 recite a cell culture membrane comprising a membrane body having a first face and a second face located on a side opposite to the first face, and a plurality of through holes penetrating from the first face to the second face (related to instant claims 1 and 3), the plurality of through holes have a first average hole diameter at the first face larger than a second average hole diameter at the second face or have a mortar shape (related to instant claim 1). The membrane body comprises polyurethane (related to instant claim 6). The second average hole diameter is 7 µm or less (related to instant claims 1 and 2). It is noted that the limitations “capable of culturing a hepatic stellate cell” and “when the hepatic stellate cell is cultured on the cell culture membrane” in instant claims 1 and 6 are directed to an intrinsic inherent property of the claimed cell culture membrane and contingent limitation that do not limit the structure of the claimed cell culture membrane. See MPEP 2145 (II) and MPEP 2111.04 II.
The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims in the copending application have not in fact been patented.
Claims 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending claim 8 of copending Application No. 17/975,037 (‘037). Although the claims at issue are not identical, they are not patentably distinct from each other.
Copending claim 8 of ‘037 recites a cell culture membrane comprising a membrane body including a first surface and a second surface located on a side opposite to the first surface, and a plurality of through holes that are formed in the membrane body and penetrate from the first surface to the second surface, wherein in the through holes, a first average pore diameter in the first surface is smaller than a second average pore diameter at the second surface (thus having a mortar shape), the surfaces are used to seed and culture different cells, the first average pore diameter is equal to or greater than 3 µm and equal to or less than 5 µm, related to instant claims 1 and 3. It is noted that the limitation “capable of culturing a hepatic stellate cell” in instant claim 1 is directed to an intrinsic inherent property of the claimed cell culture membrane that does not limit the structure of the claimed cell culture membrane. See MPEP 2145 (II).
The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims in the copending application have not in fact been patented.
Claim 6 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending claims 1-2 of copending Application No. 18/628,143 (‘143). Although the claims at issue are not identical, they are not patentably distinct from each other.
Copending claims of ‘143 recite a cell culture membrane comprising a resin porous membrane body having a plurality of pores that is open on at least one surface, at least some are through-holes that penetrate the membrane thickness, wherein the resin is a polyurethane, related to instant claim 6. It is noted that the limitations “capable of culturing a hepatic stellate cell” and “when the hepatic stellate cell is cultured on the cell culture membrane” in instant claim 6 are directed to an intrinsic inherent property of the claimed cell culture membrane and to contingent limitation that do not limit the structure of the claimed cell culture membrane. See MPEP 2145 (II) and MPEP 2111.04 II.
The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims in the copending application have not in fact been patented.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jianjian Zhu whose telephone number is (571)272-0956. The examiner can normally be reached M - F 8:30AM - 4PM (EST).
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/JIANJIAN ZHU/Examiner, Art Unit 1631
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