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 .
Priority
The instant application was filed 23 May 2024 and is the national stage entry of PCT/US2022/051231 filed 29 November 2022. The Applicant claims priority to provisional application 63/283,612 filed 29 November 20221. Therefore, the effective filing date of the instant application is 29 November 2021.
Election/Restrictions
Applicant’s election without traverse of Co2+, Cu2+, Fe2+, and Mg2+ for species A-D in the reply filed on 23 April 2026 is acknowledged.
Claim Rejections - 35 USC § 112
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 1, 3-5, 7, 8, 10-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the particles" in line 1 of claim 1. However, claim 1 recites “bioactive ceramic particles.” Claims 3-5, 7, 8, 10-20 are dependent from independent claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 1, 3, and 7 contain the trademark/trade name “bioglass.” Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe “calcium sodium phosphosilicate” and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1, 3-5, 7, 8, 10-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nimal (US 2015/0004042 A1).
Regarding claim 1, Nimal teaches ceramic powder particles (para. 133) forming layers in a biomedical composition for bone defects (abs; entire teaching). The powder is made of ceramics and/or bioactive glasses (para. 51). The powder is coated with absorbents (para. 19), such as Magnesium (para. 82) or Copper (para. 23).
Regarding claim 3, the bioactive glasses may be made from 45S5 (para. 67). 45S5 is also interpreted as being synonymous with “bioglass.”
Regarding claim 4, the composition may comprise 0.5% or less of absorbents (para. 33).
Regarding claim 5, the powder may comprise Magnesium (para. 82) and Copper (para. 23).
Regarding claim 7, the composition comprises multiple layers on top of one another (abs). the powder may be layered using a layering device, such as a roll, which is interpreted as spherical or round shaped.
Regarding claim 8, the powder is dispensed and layered joining together, layer after layer (abs), which is interpreted as sandwiched layers.
Regarding claim 10, Magnesium may be used in the powder (para. 82).
Regarding claim 11, Copper may be used in the powder (para. 23).
Regarding claim 12, the limitation “configured to be active” is interpreted as a functional limitation. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). Furthermore, the limitation “separate stage of bone healing” is interpreted as intended use. See MPEP 2111.02(II).
Regarding claim 13, the limitation “configured to be active” is interpreted as a functional limitation. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). Furthermore, the limitation “hematoma formation stage of bone healing” is interpreted as intended use. See MPEP 2111.02(II).
Regarding claim 14, the powder may comprise ions, such as Manganese (para. 23) and Cobalt (para. 23).
Regarding claim 15, the limitation “active in a soft callous formation stage of bone healing” is interpreted as intended use. See MPEP 2111.02(II).
Regarding claim 16, the powder may comprise ions, such as Copper (para. 23).
Regarding claim 17, the limitation “configured to be active” is interpreted as a functional limitation. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). Furthermore, the limitation “hard callous formation stage of bone healing” is interpreted as intended use. See MPEP 2111.02(II).
Regarding claim 18, the powder may comprise ions, such as Iron and Zinc (para. 23).
Regarding claim 19, the limitation “configured to be active” is interpreted as a functional limitation. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). Furthermore, the limitation “bone remodeling stage of bone healing” is interpreted as intended use. See MPEP 2111.02(II).
Regarding claim 29, the powder may comprise ions, such as Zinc (para. 23), Magnesium (para. 82), and Iron (para. 23).
Nimal does not teach an exact combination of the ions in the recited “groupings” or “layers” in at least claim 1.
In regards to selecting the combination of the ions in the preferred “groupings” or “layers,” “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Nimal teaches ceramic powder particles (para. 133) forming layers in a biomedical composition for bone defects (abs; entire teaching). The powder is made of ceramics and/or bioactive glasses (para. 51). The powder is coated with absorbents (para. 19), such as Magnesium (para. 82) or Copper (para. 23). However, the claimed invention is directed towards bioactive ceramic particles made of Magnesium ion and Copper ion bioglass layers. Since Nimal teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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