DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 02/28/2024, are acknowledged.
Claims 15-29 are pending in this action. Claims 1-14 have been cancelled. New claims 15-29 have been added. Claims 15-29 are currently under consideration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application is a 371 of PCT/KR2022/012954, filed August 30, 2022, which claims benefit of foreign priority to Korean Patent Applicant No. KR10-2021-0115120, filed August 30, 2021. No English translations of the certified copies of both priority application(s) have been received. Failure to provide a certified translation may result in no benefit being accorded for the non-English application. 37 CFR 41.154(b) and 41.202(e).
Inventorship
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.
Specification
The lengthy specification (92 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
The data provided in the specification are unclear, given that the data are shown with and without units of measurements (e.g., Para. 0013-0021, 0023-0024, 0080, 0085-0089, 0092, 0098-0100, 0106-0115, 0121-0124, 00147, 00165-00181, etc.). Appropriate correction is required.
The specification comprises multiple acronyms without proper definition (e.g., Para. 0032, 0034, 0050, 0051, 0053, 00258, 00368, 00369). The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
The specification comprises references on foreign application(s) and a publication(s) (e.g., Para. 0058, 0060). The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The specification comprises typographic errors, e.g., “100% whitlockite” (Para. 0077), “the whitlockite” (Para. 0092, 00147) that need to be corrected to “100% of whitlockite”, “whitlockite”, respectively. Appropriate correction is required.
Information Disclosure Statement
The information disclosure statements, filed 02/28/2024 and 03/06/2024, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
The information disclosure statements do not include Certificate Statement and Privacy Act Statement (MPEP 609), and/or do not have a signature of the applicant or representative that is required in accordance with CFR 1.33.
Claim Objections
Claims 15-29 are objected to because of the following informalities:
Claim 15 comprises the typographic error “size of 100nm to 1000nm” that needs to be corrected to “size of from 100 nm to 1000 nm”. Similar is applied to other numerical limitations recited in claim 15, as well as to claims 16-23.
Claim 16 comprises the typographic error “material of Claim 15” that needs to be corrected to “material of claim 15”. Similar is applied to claims 17-29.
Claim 16 comprises the typographic error “material is 0.15 to 0.5ml/g” that needs to be corrected to “material is from 0.15 ml/g to 0.5 ml/g” or clarified. Similar is applied to claims 17-19.
Claim 20 comprises the typographic error “a volume% of the macropores with … is 50% to 90%” that needs to be corrected to “a volume% of the macropores with … is from 50% to 90%”. Similar is applied to claims 21-23.
Claim 24 comprises the typographic error “has porosity of 60% to 95%” that needs to be corrected to “has a porosity of from 60% to 95%”.
Claim 25 comprises the typographic error “has compressive strength of 500KPa to 900KPa” that needs to be corrected to “has a compressive strength of from 500 kPa to 900 kPa” (see the instant specification Para. 00147).
Claim 26 comprises the typographic error “has specific surface area of 5m2/g to 6m2/g” that needs to be corrected to “has a specific surface area of from 5 m2/g to 6 m2/g”.
Claim 29 comprises the typographic error “consists of the whitlockite” that needs to be corrected to “consists of whitlockite”. Similar is applied to claim 15 regarding the limitation “comprising a whitlockite”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 15 recites the limitation “nanopores with size of 100 nm to 1000 nm” that is unclear and indefinite. First, it is unclear what nanopore size should be measured – radius, diameter. Second, where a claimed value (i.e., nanopore size) varies with its method of measurement and several alternative methods of measurement are available (see Wikipedia), the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). Without knowing these parameters, the metes and bounds of the claimed subject matter are not reasonably clear. Similar is applied to other pore size limitations recited in claim 15, as well as to claims 16-23. Clarification is required.
Claim 16 recites the limitation “a volume formed by the nanopores with size of 100-1000 nm per unit mass of the bone graft material is 0.15-0.5 ml/g” that is unclear and indefinite. As stated above, where a claimed value (i.e., nanopore volume) varies with its method of measurement and several alternative methods of measurement are available (see Wikipedia), the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). Without knowing these parameters, the metes and bounds of the claimed subject matter are not reasonably clear. Similar is applied to claims 17-19, as well as to claim 24 regarding the limitation “material has porosity of”, claim 25 regarding the limitation “material has a comprehensive strength of”, and claim 26 regarding the limitation “material has a specific surface area of”. Clarification is required.
Claim 28 recites the limitation “2.0 g or more per unit mass” that is not reasonably clear. In the present case, it is unclear what is disclosed as “unit mass” – mg, g, kg, etc. Clarification is required.
Claims 27, 29 are rejected as being dependent on rejected independent claim 15 and failing to cure the defect.
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.
Claims 15-29 are rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al., US 2011/0020419A1 (hereinafter referred to as Yuan), in view of Koblish et al., US 2009/0157182A1 (cited in IDS; hereinafter referred to as Koblish).
Yuan teaches a porous calcium phosphate (e.g., whitlockites) material, wherein said material may comprise both macropores and micropores (Para. 0006, 0016, 0062, 0085), and can be used for formation of bone tissue in a living organism (Para. 0100 as applied to claims 15, 29). Yuan teaches (i) the use of micropores having a size of less than 50 μm, preferably less than 10 μm, more preferably less than 1.5 μm (Para. 0056 as applied to claim 15); (ii) the material having a total porosity of from 20 to 90%, preferably from 40 to 70% (Para. 0085 as applied to claim 24); wherein (iii) a surface area percentage of micropores is in the range of 10-40% (Para. 0009 as applied to claim 26). Yuan teaches that said material (iv) can be used as a medical implant material or tissue scaffold (Para. 0017), and (v) has improved osteoinductive properties allowing faster and profound bone formation (Para. 0007, 0018).
Yuan does not teach the use/presence of macropores having a size of 100-1000 µm (claim 15).
Koblish teaches a porous bone graft material comprising calcium phosphate (claims 1, 12; Abstract; Para. 0016), and having a high porosity and broad pore size distribution (1-1000 μm; Para. 0060), wherein said material comprises: (i) macropores having diameter of 100-1000 μm; (ii) mesopores having diameter of 10-100 μm; and (iii) micropores having diameter of less than 10 μm (Claim 2; Para. 0062), and wherein a pore volume can be from 30% to 92% (Claim 3; Para. 0065). Koblish teaches that said porous bone graft material can be used for delivery of a large variety of therapeutic materials such as bone marrow aspirate, blood, plasma, cells, cell signaling materials, growth factors, proteins, or medicaments (Para. 0002). Koblish also teaches that due to the high porosity and broad pore size distribution said bone graft material can be used as implants that are not only able to wick, soak, and absorb materials very quickly, but also are capable of retaining them (Para. 0060).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include macropores having diameter of 100-1000 μm as taught by Koblish into porous calcium phosphate/whitlockites material to be used as a medical implant material as taught by Yuan. One would do so with expectation of beneficial results, because Koblish teaches that said porosity of the bone graft material can be used for delivery of a large variety of therapeutic materials allowing for sustained release them over time.
Regarding the properties of the disclosed materials, it is noted that the cited prior art teaches materials that are substantially the same as the materials recited by the instant claims. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. Further, it is noted that optimization within prior art conditions or through routine experimentation (i.e., controlling a porosity) is well within the purview of the skilled artisan for providing effective medical effect/treatment. Applicant is advised to clarify the claimed language, the structure of the claimed material/product and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615