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 .
Claim Status
Claims 1-8 are pending in the instant application.
Applicant's election with traverse of the species of “a cartilage tissue” and the species of “a poly N-substituted acrylamide derivative” in the reply filed on 10 July, 2025 is acknowledged. The traversal is on the grounds that each Markush group possesses unity of invention when considered in light of the broadest claim. This argument is not found persuasive because the broadest claim (instant claim 1) is anticipated by US 2003/0104347 A1 (Published: 5 June, 2003) (hereinafter “Mori”) (of record). Mori discloses a thermoreversible (“heat-reversible”) polymer for the preservation of biological tissues (Mori, Abstract). Therefore, the shared technical feature is not considered a special technical feature and the species lack unity of invention.
Upon further consideration, the Examiner has withdrawn both of the requirements for an election of species.
Therefore, claims 1-8 are pending and are the subject of the present Official Action.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/JP2021/006281, filed 19 February, 2021, which claims priority to Japan Application No. JP2020-028227, filed 21 February, 2020. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copies of papers required by 37 CFR 1.55 have been filed in this application on 19 August, 2022.
The earliest possible priority for the instant application is 21 February, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 23 August, 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement filed 04 June, 2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Objections
Claim 7 objected to because of the following informalities: “comprising” is incorrectly conjugated, the claim should instead recite “comprises”. Appropriate correction is required.
Claim Interpretation
Independent claim 1 is directed to a composition. Dependent claims 2-6, and 8 recite intended uses for that composition. For the purpose of examining the product that claims 1-6, and 8 are directed to, the intended uses may limit ant define the product but a determination of patentability is based upon the product itself. The intended use limitations will only be afforded patentable weight if they impart further structural limitations on the product itself. Since the limitations in claims 2-6, and 8 are solely intended use limitations, claims 1-6, and 8 are interpreted as being directed to the same product for the purpose of applying art.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2003/0104347 A1 (Published: 5 June, 2003) (hereinafter “Mori”) (of record).
Mori discloses a thermoreversible (“heat-reversible”) polymer for the preservation of biological tissues (Mori, Abstract). The broadest reasonable interpretation of “biomaterial” encompasses the biological tissues of Mori. The polymer of Mori is a hydrogel that undergoes a solution (sol) to gel (gel) transition with changes in temperature and Mori discloses that the gel is thermos-reversible (Mori, Abstract, [0018], Fig. 1). Thus, Mori discloses the invention claimed in instant claim 1. Regarding claim 2, the intended use of “for preservation at a constant or varying temperature” adds no further structure to the composition claimed in claim 1 (see claim interpretation above). Thus, Mori discloses the composition of claim 2. Assuming arguendo that the intended use of claim 2 can be interpreted as adding any structure to the composition of claim 1, Mori also discloses a method of preserving biological tissues comprising applying the composition in the solution (sol) state, then raising (varying) the temperature to convert the composition to a gel state and coat the biological tissue. Regarding claims 3 and 4, the intended uses of “wherein the constant or varying temperature is a temperature at which a cell does not substantially proliferate” and “wherein the temperature at which a cell does not substantially proliferate is between 4 and 30[degrees] C” add no further structure to the composition claimed in claim 1 (see claim interpretation above). Thus, Mori discloses the composition of claims 3 and 4. Assuming arguendo that the intended uses of claims 3 and 4 can be interpreted as adding any structure to the composition of claim 1, Mori also discloses that the sol-gel transition of their compositions are 10, 20, or 35 degrees C (Mori, [0207]) and that the temperature at which the tissue is preserved is not more than 20 degrees C (Mori, [0189]). Regarding claims 5 and 6, the intended uses which define biomaterials which may be preserved by the composition add no further structure to the composition claimed in claim 1 (see claim interpretation above). Thus, Mori discloses the composition of claims 5 and 6. Assuming arguendo that the intended uses of claims 5 and 6 can be interpreted as adding any structure to the composition of claim 1, Mori also discloses that the tissue can be gullet, stomach, small intestine, colon, pancreas, liver, skin, blood vessel, bone, cornea, skin, red blood cells, white blood corpuscle, blood platelet, T cells, dendritic cells, embryo cells, embryonic stem cells, or fertilized ovum (Mori, [0161]-[0165]). Regarding claim 7, Mori discloses explicitly that plural blocks having a cloud point preferably comprises polymer blocks selected from a polypropylene oxide, copolymers of polypropylene oxide, poly N-substituted acrylamide derivatives, poly N-substituted methacrylamide derivatives, copolymers comprising poly N-substituted acrylamide derivatives and poly N-substituted methacrylamide derivatives, polyvinyl methyl ether, and partially acetylated polyvinyl alcohol with a hydrophilic block bound thereto (Mori, [0113]). Regarding claim 8, the intended use of “wherein the preserving composition can also be used for transportation” adds no further structure to the composition claimed in claim 1 (see claim interpretation above). Thus, Mori discloses the composition of claim 8. Assuming arguendo that the intended use of claim 8 can be interpreted as adding any structure to the composition of claim 1, Mori also discloses that the composition can be used for the transportation of the tissue (Mori, [0066], [0195]). Therefore, Mori anticipates the invention claimed in instant claims 1-8.
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 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-22 of copending Application No. 18027892 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to a method of using the composition instantly claimed.
Reference claim 11 recites “A method for increasing tissue regeneration capacity of a cell population, comprising a step of incubating the cell population in a thermoreversible polymer solution in a gel state.”
Reference claim 18 recites “wherein the thermoreversible polymer is obtained by binding hydrophilic blocks and a plurality of blocks having cloud point selected from a group of a copolymer of polypropylene oxide or propylene oxide with other alkylene oxide, a copolymer of poly N-substituted acrylamide derivatives, poly N-substituted methacrylamide derivatives, N-substituted acrylamide derivatives or N-substituted methacrylamide derivatives, polyvinyl methyl ether, and partially acetylated polyvinyl alcohol.”
Thus, the method of the reference requires a similar if not identical composition to that instantly claimed in claim 1. Therefore, the composition of claim 1 would be obvious to a person having ordinary skill in the art over the method of using the composition in the reference application because the compositions of the reference application and the instant composition are the same. Dependent claim limitations found in instant claim 7 are found in the reference claim 18. Further, the compositions of instant claims 1-6, and 8 are interpreted as the same composition for the purpose of applying art because dependent claims 2-6, and 8 merely add intended use limitations (see claim interpretation above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 17601861 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to a method of using the composition instantly claimed.
Reference claim 1 recites “A method of producing a chondrocyte culture with high havinq an increased tissue-regenerating ability, the method comprising a step of;culturing a cell population separated from cartilage tissue with a thermoreversible gelation polymer separating a chondrocyte cell population from a cartilage tissue;obtaining a thermoreversible gelation polymer, the polymer including a macromolecule having a clouding point temperature in water that is higher than 40C and not higher than 40°C the macromolecule selected from the group consisting of polypropylene oxide; polyvinyl methyl ether; acetylated polyvinyl alcohol;polylactic acid; polyglycolic acid; poly N-substituted acrylamide; polyvinyl methyl ether, and partially acetylated polyvinyl alcohol; poly-N-acryloyl piperidine; poly- N-n-propyl methacrylamide; poly-N-isopropyl acrylamide; poly-NN- diethylacrylamide; poly-N-isopropyl methacrylamide; poly-N-cyclopropyl acrylamide; poly-N-acryloyl pyrrolidine; poly-NN-ethylmethyl acrylamide; poly-N- cyclopropyl methacrylamide; and poly-N-ethyl acrylamide; and,a hydrophilic block macromolecule selected from the group consisting of methyl cellulose, dextran, polyethylene oxide, polyvinyl alcohol, poly N-vinylpyrrolidone,polyvinyl pyridine, polyacrylamide, polymethacrylamide, poly N-methyl acrylamide, polyhydroxymethyl acrylate, polyacrylic acid, polymethacrylic acid,polyvinyl sulfonate, polystyrene sulfonate and salts thereof; poly NN- dimethylaminoethyl methacrylate, poly NN-diethylaminoethyl methacrylate, poly N,N-dimethylaminopropyl acrylamide, and salts thereof;wherein, the macromolecule having the clouding point is bound by the hydrophilic block macromolecule, and the combination of the macromolecule and the hydrophilic block macromolecule creates the thermoreversible gelation polymer with a sol- qel temperature that is higher than 0C and not hiqher than 370C;dispersing the chondrocyte cell population into a solution of the thermoreversible gelation polymer to create a chondrocyte cell mixture above the sol-qel temperature;adding a culture media to the chondrocyte cell mixture to create a chondrocyte culture;qelling the chondrocyte culture above the sol-qel temperature;culturing the chondrocyte culture to obtain a chondrocyte tissue regeneration;stimulatinq the increased chondrocyte tissue regeneration by increasing the expression of one or more genes selected from SOX9, COL2A1, miR140 and miR21 when compared to anexpressing of the one or more genes in the chondrocyte culture without the thermoreversible qelation polymer;collecting the chondrocyte tissue from the chrondrocyte culture, the collecting including cooling the chondrocyte culture below the sol-qel temperature to convert the qelled combination of the macromolecule and the hydrophilic block macromolecule back to an aqueous solution of the combination of the macromolecule and the hydrophilic block macromolecule.”
Thus, the method of the reference requires a similar if not identical composition to that instantly claimed in claim 1. Therefore, the composition of claim 1 would be obvious to a person having ordinary skill in the art over the method of using the composition in the reference application because the compositions of the reference application and the instant composition are the same. Dependent claim limitations found in instant claim 7 are found in the reference claim 1 as well. Further, the compositions of instant claims 1-6, and 8 are interpreted as the same composition for the purpose of applying art because dependent claims 2-6, and 8 merely add intended use limitations (see claim interpretation above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDAN THOMAS TINSLEY whose telephone number is (703)756-5906. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRENDAN THOMAS TINSLEY/Examiner, Art Unit 1634
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638