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 .
Information Disclosure Statement
The submitted information disclosure statement (IDS) were filed on 08/26/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 non-obviousness.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 20190117826 A1), Shen et al. (CN 101991600 A), Dai et al. (CN 108379666 B), Cashman et al. (CA 3131352 A1) and Santini et al. (US 20070016163 A1).
Claim 1,
Lin et al. teach a method for treating a subject comprising providing the bone implant preparation as set forth in claim 1; and filling a hole or cavity in a bone of said subject with said bone cement paste, which set hard in the hole or cavity in need of said treatment. (Claim 11, pg. 13). A bone implant preparation, which is composed of a free-flowing powder component, and an aqueous solution free of lithium ions, said bone implant preparation consists of a calcium compound and a lithium compound. (Claim 1, pg. 13). A preparation at least useful as a bone implant, which contains a solid component including a lithium compound and a calcium compound. (Abs).
Lin et al. do not teach a method for killing osteosarcoma cells with a bone cement preparation after a surgical treatment for removal osteosarcoma from a patient.
Shen et al. teach lithium salts, pharmaceutically accepted or used, having internal and external anti-osteosarcoma function, for treatment of osteosarcoma. (Abs, 0001).
Dai et al. teach researchers have the double effects of repairing bone defect and bone disease in the medicine loading bone cement with-calcium phosphate for the local delivery of medicine paclitaxel to bone. Loading paclitaxel into injectable bone cement and performing cell experiment; obtaining the activity of and metastatic breast cancer cells in the drug-loaded group is lower than the drug-free group; the medicine can reach a certain medicine effect bone cement. (pg. 2, 3rd par.).
Cashman et al. teach medical application to treat human bone injury and promote bone repair, as well as to promote spinal fusion by implanting surgical cages using standard techniques in the field wherein the surgical cages contain the compositions of the invention. Human bone diseases include may be related to cancer, such as osteosarcoma or other cancers that has disseminated to bone. (00316). Compositions of small molecules, matrices, into the osteoblast cell lineage that is used for therapeutic purposes. Small molecule-stimulated cells were also combined with a matrix, placed with a cellular adhesive or material carrier and implanted to a site in an animal for bone repair. (Abs).
Santini et al. teach osteosarcoma or chondrosarcoma often are treated surgically by excision requiring removal of significant amounts of bone and soft tissue. Care must be taken to avoid spilling the tumor during resection to avoid seeding of tumor cells into surrounding tissues. It therefore would be beneficial for the prosthetic implant to release one or more local chemotherapeutic agents into the surrounding tissue following implantation, in order to destroy tumor cells remaining at the surgical site following resection, to complement or replace the systemic chemotherapy and/or radiation therapy that typically is prescribed for the patient. (0041).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to treat a subject by implanting in a bone cavity a bone cement composed of lithium compound and calcium compound, taught by Lin et al.; lithium salts has anti-osteosarcoma function, for treatment of osteosarcoma, taught by Shen et al.; calcium phosphate in bone cement providing double effects of repairing bone defect and bone disease in the medicine and in cancer treatment taught by Dai et al., and material carrier and implanted to a site in an animal for bone repair, taught by Cashman et al., and a bone cement implant of some ingredients killing osteosarcoma cells after a surgical treatment for removal osteosarcoma, taught by Santini et al., since they have proven they are the feasible steps to do for osteosarcoma treatment.
With regard to claim 2,
Lin et al. teach the bone implant preparation of claim 1, wherein the lithium compound is present in an amount of 5-80%, based on the weight of the bone implant. (Claim 2, pg. 13).
With regard to claims 3-5,
Lin et al. teach Preferably, the lithium compound is a lithium salt, lithium oxide, lithium amide (LiNH2), lithium hydroxide or lithium halide; and more preferably lithium carbonate, lithium sulfate, lithium phosphate, lithium oxide, lithium fluoride, lithium acetate, lithium bromide, lithium hydroxide, lithium nitrate, lithium nitrite, lithium iodide, lithium molybdate (Li2MoO4), lithium tetraborate (Li2B4O7), lithium citrate tetrahydrate (Li3C6H5O7.4H2O), or lithium stearate (LiC18H35O2); and most preferably lithium carbonate, or lithium phosphate. (0011).
With regard to claims 3 and 5,
Shen et al. teach lithium salts, selected from lithium chloride, lithium carbonate, lithium sulfate, lithium citric acid, and other lithium salt pharmaceutically accepted or used, having internal and external anti-osteosarcoma function, for treatment of osteosarcoma. (Abs, 0001).
With regard to claims 3 and 6,
Cashman et al. teach the matrix including, calcium carbonates, calcium sulfates, , calcium chloride, calcium fluoride, calcium phosphates, calcium sulfate, calcium oxide, lithium chloride, lithium fluoride, ammonium, or organic cation salts of nitrates, carbonates, phosphates, sulfates, halides, oxides, or other salts of lithium, bone cement or combinations thereof. (00165-00167).
With regard to claim 6,
Lin et al. teach the calcium compound is selected from the group consisting of calcium phosphate, calcium sulfate, calcium oxide, calcium carbonate, calcium hydroxide, calcium magnesium phosphate, calcium nitrate, calcium citrate, calcium chloride and a mixture thereof. (Claim 1, pg. 13).
With regard to claims 7-8,
Lin et al. teach the solid component is a powder component comprising the lithium compound and the calcium compound, wherein the calcium compound is selected from the group consisting of a calcium phosphate, calcium sulfate, calcium oxide, calcium carbonate, calcium hydroxide, calcium magnesium phosphate, calcium nitrate, calcium citrate, calcium chloride and a mixture thereof; and more preferably the calcium compound is a calcium sulfate, a calcium phosphate source, or a mixture thereof. Preferably, the calcium phosphate is tetracalcium phosphate (TTCP), dicalcium phosphate, tricalcium phosphate, monocalcium phosphate or a mixture thereof. Preferably, the calcium sulfate is calcium sulfate hemihydrate (CSH), calcium sulfate dehydrate (CSD), anhydrous calcium sulfate, or a mixture thereof. (0012).
With regard to claim 9,
Lin et al. teach optionally one or more components selected from the group consisting of a growth factor, a bone morphogenetic protein (BMP), living cells, a drug, and a poly(acrylic acid), wherein the free-flowing powder component is to be mixed with the aqueous solution at a ratio of aqueous solution to powder of 0.20 ml/g to 0.80 ml/g to form a bone cement paste, which will then set hard to form a bone implant, when the poly(acrylic acid) is present, it is present in the amount of 0.01-5% of the poly(acrylic acid), based on the total weight of the bone implant. (Claim 1, pg. 13).
With regard to claim 10,
Lin et al. teach Preferably, the solid component is a block, or granules or pieces obtained by breaking up said block. The block comprises the lithium compound and the calcium compound, wherein the calcium compound is selected from the group consisting of calcium phosphate, calcium sulfate, calcium oxide, calcium carbonate, calcium hydroxide, calcium magnesium phosphate, hydroxyapitite, or a mixture thereof, and preferably is selected from the group consisting of tetracalcium phosphate, dicalcium phosphate, hydroxyapitite, calcium sulfate dihydrate, calcium sulfate hemihydrate, or a mixture thereof. (0015). The present invention also provides a method for treating a subject comprising implanting said block, said granules or said pieces of the anti-bacterial preparation of the present invention in said subject in need of said treatment. (0016).
Cashman et al. teach "Matrix" refers generally to a substance or material that provides a two dimensional or three-dimensional environment distinct from that of the surroundings. The term as used herein generally refers to naturally occurring or synthetic materials that provide one or more environments such as an outer or internal surface, an internal volume of a cavity, or the matter that comprises the matrix itself. For example, matrices of the disclosure include solid, semisolid and liquid states of matter. By way of further example, matrices of the disclosure include solid matter that extends in size from nanometers to meters and may further take the form of porous or non-porous, permeable or non-permeable, soluble or colloidal substances, while semisolid and liquid states of matter may be porous or non-porous, permeable or non-permeable, colloidal or soluble forms. (0035). The matrix is independently and optionally comprised of synthetic or naturally-occurring substances in a two-dimensional or three-dimensional framework that may extend in size from nanometer to multiple meters and so may consist of nanoparticles, microparticles, macroparticles and other macro-objects such as sheets, planes, beds, blocks, fibers, meshes, gels, networks, and lattices. (00165-00167).
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 12-13 of U.S. Patent No. US 10,207,023 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the later-submitted claims are considered an obvious variation or are fully anticipated by the earlier patent or application's claims.
Conclusion
No claim is allowed.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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