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 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.
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 nonobviousness.
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.
1) Claims 1-5, 7, 8, 12, 13, 17, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Vanderploeg et al. (US 2017/0209623 A1, publication date 07/27/2017) in view of Hu et al. (CN 108114316 A, publication date 05/06/2018; citing English machine translation), Kapoor et al. (AIP Conf. Proc. 1393, 2011, 375-376) and Safronova et al. (Materials Research Society, 2005, 887), as evidenced by Ferriol et al. (Polymer Degradation and Stability, 2003, vol. 79, p. 271-281).
Regarding instant claims 1-5, 7, 8, 12, 13 and 20, Vanderploeg discloses “[s]ystems and methods for preparing osteoinductive synthetic bone grafts are provided in which a porous ceramic granule, which may be incorporated within a biocompatible matrix material” (i.e., product comprising granules dispersed within and in contact with the biocompatible matrix; instant claims 4, 5 and 20) [abstract]. The granules include material such as sintered hydroxyapatite (i.e., instant claim 12) [0020]. The biocompatible matrix is, in various embodiments, hyaluronic acid (HA) (i.e., biodegradable carrier according to instant claim 13) [0022]. Vanderploeg further discloses the granule may have a specific surface area greater than 30 m2/g [0006] and a diameter of about 425 μm to about 800 μm [p. 8, claim 1].
Vanderploeg does not discloses the specific steps for sintering hydroxyapatite.
Hu discloses a ceramic-based dental bone powder with excellent bone repair effect and low production cost [abstract]. In one example, the powder preparation comprises sintering a mix of hydroxyapatite and polyvinyl alcohol (i.e., a biocompatible binder according to the instant specification at line 12 of page 6) [p. 8, third to last para. to p. 9, third para.]. According to Hu, sintering comprises a first stage at temperatures from 500 to 600 degrees centigrade and a second stage at temperatures from 1200 to 1500 degrees centigrade [abstract]. Hu also discloses the hydroxyapatite sintering solution comprises PMMA particles, understood to be poly(methyl methacrylate), which are included to control the porosity of the sintered hydroxyapatite particle [p. 5, last para.]. Finally, Hu discloses the final powder is obtained by crushing and sieving the sintered material [p. 9, para. 5].
Hu does not disclose sintering at temperature lower than 1200 deg. C.
Kapoor relates to sintering of hydroxyapatite powder for tissue engineering and bone repair [title and first two sentences of abstract]. Specifically, Kapoor studied the effect of sintering temperature of hydroxyapatite (HAP) nano-powder [abstract]. Kapoor found that “[t]he synthesized nano-HAP powder was found to be stable up to 1000[deg.]C without any additional phase other than HAP, whereas peak of β-TCP (tricalcium phosphate) was observed at 1200[deg.]C. Photomicrograph of TEM showed that the nanopowder sintered at 600 [deg.]C is composed of hydroxyapatite nanoparticles (26.0–45.6 nm)” [abstract].
Safronova relates to the effects of polyvinyl alcohol (PVA) on sintering hydroxyapatite (HAp) [title & abstract, last sentence]. Safronova discloses that “[a]ddition of PVA to the stock solution in the course of HAp precipitation is a promising technique to control an aggregation of HAp nanoparticles in the stages of drying and sintering. PVA acting as a surfactant in the solution and as a binder in dry powder can keep highly reactive small HAp particles within large agglomerates providing better molding of the powder and controllable densification of ceramics” [abstract, last para.]. According to Safronova “[r]eduction of sintering temperature from 1150°С according to the data [13] down to 900-950°С in our work (which is of special interest) can originate from higher sintering activity of the powder under study” [p. 5, penultimate paragraph].
The PMMA would have been completely removed at temperatures above 700K (i.e., 427 degrees centigrade) [pages 273-274, figures 1-2], as evidenced by Ferriol at pages 273-274, figures 1-2.
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have to selected the sintered hydroxyapatite powder of Hu as the sintered hydroxyapatite granule desired by Vanderploeg because Hu discloses it has excellent bone repair effect. One would have been further motivated to make this selection because Hu discloses it has low production cost. One would have had an expectation of success because the powder disclosed by Hu comprises sintered hydroxyapatite granules for bone repair, as desired by Vanderploeg. Additionally, one would have had an expectation of success in providing hydroxyapatite with the physical characteristics (i.e., surface area and diameter) desired by Vanderploeg because Hu discloses they may be controlled with the PMMA particles.
Furthermore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have modified the methods of Hu by lowering the sintering temperature to the less than 1000 deg. C disclosed by Kapoor. One would have been motivated to lower the temperature because Kapoor discloses hydroxyapatite powder is stable up to 1000 deg. C. One would have also been motivated because Hu desire a composition comprising hydroxyapatite and Kapoor discloses that beta-tricalcium phosphate begins to form at 1200 deg. C. One would have had an expectation of success in lowering the temperature in the methods disclosed by Hu because Safronova discloses that when combined with PVA, hydroxyapatite can be effectively sintered at 900-950 deg. C. Additionally, in making this modification, one would have expected nothing more than predictable results. See MPEP 2143, Exemplary Rationale C.
Finally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the ranges discloses by Vanderploeg for surface area (greater than 30m2/g) and particles diameter (about 425 microns) overlap with the instantly claimed ranges for specific surface area (more than 0.1m2/g; instant claim 7) and diameter (1 μm to 1000 μm; instant claim 9) and a prima facie case of obviousness exists for both. The temperature range for the first heat treatment of Hu (500-600 deg. C) also overlaps with the instantly claimed range, and so a prima facie case of obviousness exists.
Therefore it, would have been obvious for one of ordinary skill in the art, at the time of filling, to have formulated a composite filler (product) comprising porous hydroxyapatite particles dispersed within, and in contact with, hyaluronic acid as a biodegradable carrier, wherein the particles have a size and surface area within the instantly claimed ranges. Wherein the inorganic particles (hydroxyapatite) are obtained by heat treating a biocompatible binder (PVA) and calcium based particles to a first heat treatment as instantly claimed and a second heat treatment as instantly claimed. Additionally, because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e. bioactivity as recited in instant claims 2 and 3.
Regarding instant claim 17, Hu discloses the powder preparation comprises sintering a mix of 15 g hydroxyapatite and 1.5 ml of a 0.1 g/ml solution of polyvinyl alcohol (i.e., 100:1 hydroxyapatite to PVA mass ratio) [p. 8, third to last para. to p. 9, third para.].
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed range of 5-100:1 hydroxyapatite to PVA overlaps with the range of the prior art and so a prima facie case of obviousness exists.
Regarding instant claims 20 and 21, Vanderploeg, Hu, Kapoor and Safronova, which are taught above, differ from instant claims 20 and 21 only insofar as they do not disclose a weight ratio of hydroxyapatite to polyvinyl alcohol (PVA) from 40:1 to 50:1.
Safronova discloses that “[a]ddition of PVA to the stock solution in the course of HAp precipitation is a promising technique to control an aggregation of Hap nanoparticles in the stages of drying and sintering” [p. 5, Conclusion]. Safronova also teaches that the concentration of PVA effects the properties of the hydroxyapatite by disclosing “[a]n increase in the PVA content from 0.25 to 0.5% makes the aggregates larger, stronger, and denser” (see [p. 4, para. 2] and Figure 2 on page 5).
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising PVA within the instantly claimed weight ratio to hydroxyapatite through routine optimization. It has been held that it is not inventive to discover the optimum workable ranges by routine experimentation where, as is here, the general conditions of the claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would have been motivated to optimize the PVA and hydroxyapatite mixture of Hu in order to tune the aggregation of the hydroxyapatite particles. One would have had an expectation of success because Safronova teaches the amount of PVA affects hydroxyapatite aggregation.
2) Claims 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Vanderploeg et al. (US 2017/0209623 A1, publication date 07/27/2017) in view of Hu et al. (CN 108114316 A, publication date 05/06/2018; citing English machine translation), Kapoor et al. (AIP Conf. Proc. 1393, 2011, 375-376) and Safronova et al. (Materials Research Society, 2005, 887), as evidenced by Ferriol et al. (Polymer Degradation and Stability, 2003, vol. 79, p. 271-281), as applied to claims 1-5, 7, 8, 12, 13, 17 and 20-22 above, and further in view of De Bruijn et al. (EP 1,829,564 A1, publication date 09/05/2007), as evidenced by Chemical Book (hydroxyapatite, chemical book, 2025 [2025], https://www.chemicalbook.com/ChemicalProductProperty_EN_CB2131094.htm).
Vanderploeg, Hu, Kapoor and Safronova, which are taught above, differ from the instant claims insofar as they do not teach the total pore volume and a diameter of within 1 μm and 100 μm. Hu does disclose the sintered particles are sized by crushing the particles [p. 9, para. 5].
De Bruijn discloses “relates to an osteoinductive biomaterial based on calcium phosphate, wherein the material is in the form of microparticles having a particle size ranging from about 50 to about 1500 μm” [abstract]. According to De Bruijn the physical characteristics of the sintered particle provide osteoinductive properties that are improved over the materials of the prior art [0008]. Additionally, the total porosity of the particles is from 20 to 90% [0031]. The particle size is achieved by “milling the sintered calcium phosphate ceramic to particles and collecting the particles having a particle size ranging from about 50 to about 1500 μm” [0016].
A hydroxyapatite particle with a diameter of 100 μm (i.e., volume of about 263 μm3) and a total porosity of 90% would have had a total pore volume of about 237 μm3 (0.00000237 cm3). The solid hydroxyapatite left would have been about 26 μm3 (0.00000026 cm3) and therefore the total weight would have been 0.0000008 g (hydroxyapatite density: 3.16 g/cm3, as evidenced by Chemical Book at Properties). Therefore, the total pore volume may be expressed as
0.00000237
c
m
3
0.0000008216
g
or 2.96 cm3/g.
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have crushed (milled) the particles of Hu to the size disclosed by De Bruijn. It also would have been obvious to one of ordinary skill in the art, at the time of filling, to have adjusted the porosity of the particles disclosed by Hu to be within the range taught by De Bruijn. One would have been motivated to make the particles of Hu with the size and porosity of De Bruijn because De Bruijn discloses that size and porosity provide improved osteoinductive properties. One would have had an expectation of success because both Hu and De Bruijn discloses porous hydroxyapatite particles that are crushed (milled) to size. Hu also provides a means to adjust the size of the sintered particles (crushing) and the porosity of the particles (PMMA particles). Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, the ranges for particle size and total pore volume disclosed in the prior art (50 to about 1500 μm and about 2.96 cm3/g) overlap with the corresponding instant claimed ranges (1 to about 100 μm and at least 0.001 cm3/g; instant claims 18 and 6). Therefore, a prima facie case of obviousness exists for both ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to formulated the composition taught by Vanderploeg, Hu, Kapoor and Safronova to comprise inorganic particles with a total pore volume and diameter within the instantly claimed ranges.
3) Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Vanderploeg et al. (US 2017/0209623 A1, publication date 07/27/2017) in view of Hu et al. (CN 108114316 A, publication date 05/06/2018; citing English machine translation), Kapoor et al. (AIP Conf. Proc. 1393, 2011, 375-376) and Safronova et al. (Materials Research Society, 2005, 887), as evidenced by Ferriol et al. (Polymer Degradation and Stability, 2003, vol. 79, p. 271-281), as applied to claims 1-5, 7, 8, 12, 13, 17 and 20-22 above, and further in view of Groot-Barrere et al. (NL 2011195 C2, publication date 01/21/2015).
Vanderploeg, Hu, Kapoor and Safronova, which are taught above, differ from the instant claims insofar as they do not disclose acicular shaped calcium-based particles (porous ceramic particle). Acicular is understood to mean shaped like a needle.
Groot-Barrere relates to osteoinductive calcium phosphate particles [abstract]. The particles comprise hydroxyapatite [p. 3, lines 5-6] and the transformation from grain-like to needle-like is associated with an increase in specific surface area and pore area [p. 3, lines 16-18]. The size of the needles is typically from 10 to 1500 nm [p. 5, lines 12-14].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have provided the hydroxyapatite particles of Hu as needle-like particles because Groot-Barrere discloses it improves surface area and pore volume. On would have has an expectation of success because Groot-Barrere discloses grain-like particles may be transformed into needle-like particles. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Additionally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the particle size of the prior art overlaps with the particle size ranges of instant claims 9 and 11 (10 nm to 10 microns and 100 nm to 10 microns; respectively) and a prima facie case of obviousness exists for both ranges.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated the composition taught by Vanderploeg, Hu, Kapoor and Safronova with needle-like calcium-based sintered particles having a diameter within the instantly claimed ranges.
4) Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Vanderploeg et al. (US 2017/0209623 A1, publication date 07/27/2017) in view of Hu et al. (CN 108114316 A, publication date 05/06/2018; citing English machine translation), Kapoor et al. (AIP Conf. Proc. 1393, 2011, 375-376) and Safronova et al. (Materials Research Society, 2005, 887), as evidenced by Ferriol et al. (Polymer Degradation and Stability, 2003, vol. 79, p. 271-281), as applied to claims 1-5, 7, 8, 12, 13, 17 and 20-22 above, and further in view of Ying et al. (US 6,013,591 A, date of patent 01/11/2000).
Vanderploeg, Hu, Kapoor and Safronova, which are taught above, differ from the instant claims insofar as they do not disclose a spherical calcium-based particles with a diameter between 100 nm and 10 microns.
Ying relates to the synthesis of nanocrystalline appetites for implants [abstract] Ying discloses that “[t]he bioceramic material of the invention having very small crystal sizes make it ideal for powders or coatings, and for use with bones. The crystal size of healthy bone is approximately 20–30 nm, and bioceramic material having similar crystal size will be better compatible with bone as a result. In particular, the invention provides compositions including particulate material, preferably apatite, having an average crystal size of less than 250 nm” [col. 10, lines 51-60]. Additionally, the particles are spherical [col. 36, claim 1]. Ying also discloses that “[b]y minimizing particle size, packing and densification is enhanced resulting in the fabrication of densified nanocrystalline hydroxyapatite by using a simple pressureless sintering process at relatively low sintering temperatures. By reducing crystallite size, ceramics become more ductile as the volume fraction of grain boundaries increases allowing grain boundary sliding” (emphasis added) [col. 5, lines 49-55].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected the size and shape of the hydroxyapatite particles of Ying for the sintered hydroxyapatite particles desired by Vanderploeg and taught by Hu. On would have been motivated because Ying discloses those properties enhance densification and provide particles that are more ductile. One would have had an expectation of success because the particles of Ying are hydroxyapatite particles for use with bones, as desired by Vanderploeg and Hu.
Additionally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the particle size of the prior art overlaps with the particle size ranges of instant claims 9 and 11 (10 nm to 10 microns and 100 nm to 10 microns; respectively) and a prima facie case of obviousness exists for both ranges.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated the composition taught by Vanderploeg, Hu, Kapoor and Safronova with spherical calcium-based sintered particles having a diameter within the instantly claimed ranges.
5) Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Vanderploeg et al. (US 2017/0209623 A1, publication date 07/27/2017) in view of Hu et al. (CN 108114316 A, publication date 05/06/2018; citing English machine translation), Kapoor et al. (AIP Conf. Proc. 1393, 2011, 375-376) and Safronova et al. (Materials Research Society, 2005, 887), as evidenced by Ferriol et al. (Polymer Degradation and Stability, 2003, vol. 79, p. 271-281), as applied to claims 1-5, 7, 8, 12, 13, 17 and 20-22 above, and further in view of Shanghai Rebone Biomaterials Co Ltd (CN 107029295 A, publication date 08/11/2017; citing English machine transition; hereinafter “Shanghai”).
Vanderploeg, Hu, Kapoor and Safronova, which are taught above, differ from the instant claims insofar as they do not disclose the ratio of inorganic particles (sintered hydroxyapatite) to biodegradable carrier (biocompatible matrix). Vanderploeg discloses that in addition to hyaluronic acid, gelatin is a suitable biocompatible matrix [0022].
Shanghai discloses a composition useful for producing tissue growth [p. 5, last para.]. The composition comprises crystallized (sintered) calcium phosphate particles, such as hydroxyapatite, and a hydrogel, such a gelatin hydrogel [abstract and p. 4, first half]. The mass ratio of the hydrogel monomer to water for injection is from 1:99 to 1:4 [abstract]. The mass ratio of crystallized calcium phosphate to hydrogel prepolymer is from 1:19 to 1:1 [abstract]. Therefore, assuming the crystallized calcium phosphate to hydrogel prepolymer ratio is 1:1 as disclosed, Shanghai teaches a mass ratio of crystallized calcium phosphate to carrier of 1:99 to 1:4 (i.e., 1:99 to 25:100).
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
In the present case, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected the ratio taught by Shanghai for the composition disclosed by Vanderploeg because Shanghai discloses it is a suitable ratio for tissue growth compositions. One would have had an expectation of success because Shanghai discloses a tissue growth composition comprising sintered hydroxyapatite and gelatin as the carrier which is similar to the composition disclosed by Vanderploeg.
Additionally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case the range of the inorganic particle to carrier ratio of the prior art (1:99 to 25:100) overlaps with the instantly claimed range (1:100 to 50:100), and a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated the composition taught by Vanderploeg, Hu, Kapoor and Safronova such that the mass ratio of the inorganic particle (sintered hydroxyapatite) to biodegradable carrier (gelatin) is within the instantly claimed range.
6) Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Vanderploeg et al. (US 2017/0209623 A1, publication date 07/27/2017) in view of Hu et al. (CN 108114316 A, publication date 05/06/2018; citing English machine translation), Kapoor et al. (AIP Conf. Proc. 1393, 2011, 375-376) and Safronova et al. (Materials Research Society, 2005, 887), as evidenced by Ferriol et al. (Polymer Degradation and Stability, 2003, vol. 79, p. 271-281), as applied to claims 1-5, 7, 8, 12, 13, 17 and 20-22 above, and in further view of Bastan et al. (Materials and technology, 2013, vol. 47, issue 3, pages 303-306).
Vanderploeg, Hu, Kapoor and Safronova, which are taught above, differ from the instant claims insofar as they do not disclose spray drying. Hu does teach that the solution of hydroxyapatite may be dried before sintering [p. 6, 8th to last line and p. 12, claim 5].
Bastan investigates the effects of binders and spray drying on sintered hydroxyapatite solutions [abstract]. The hydroxyapatite powders were mixed with a binder solution of polyvinyl alcohol and ethanol to create a slurry that was spray dried and then sintered [p. 305, left col., last para. to right col., first para.]. Bastan found that “[s]pray-dried powder with the correct particle size is converted to flame spheroidized powder so as to improve the microstructural characteristics and the stability of the powder” [p. 305, last para.].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have simply substituted the drying method of Hu for the spray drying disclosed by Bastan. The skilled artisan would have been motivated to make this substitution because Bastan discloses is provides improved powder stability. One would have had a reasonable expectation of success because both Bastan and Hu disclose sintering hydroxyapatite with polyvinyl alcohol as the binder. The simple substitution of one known element (e.g., the spray drying of Bastan) in place of another (e.g., the drying of Hu) in order to achieve predictable results (drying the sintering slurry of hydroxyapatite and PVA) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have sintered the spray dried product of the calcium-based particles (hydroxyapatite) and the biocompatible binder (polyvinyl alcohol).
Response to Arguments
1) On page 9 and 10 of their remarks, Applicant argues Vanderploeg and Hu do not provide motivation for the instantly claimed temperature range.
This argument is moot in view of the new rejections necessitated by amendment.
2) On page 9 of their remarks, Applicant asserts that at temperatures above 1200 deg. C hydroxyapatite loses porosity and the bioactively is reduced. Applicant cites the instant specification at page 7 and comparative example 1 for support (see Table 1-2, p. 18-19)
This argument is moot in view of the new rejections necessitated by amendment. However the Examiner respectfully notes specification discloses “if sintering temperature is excessively increased to more than 1200 deg. C, the pores can be completely removed” [p. 7]. In other words the specification does not appear to indicate the temperature range as critical because it merely discloses there is a chance the pores are removed at temperatures above 1200 deg. C. Furthermore, comparative example 1 discloses temperature treatment of 1200 deg. C, not a temperature excessively increased to more than 1200 deg. C (see instant speciation at page 16, line 16).
3) On page 10 of their remarks, Applicant asserts that when the content of calcium-based particles is excessive increased with respect to 1 part by weight of the binder it is difficult for the composition particles to form spheres during spray drying. Applicant cites the first paragraph of page 8 in the instant specification for support.
This argument is moot in view of the new rejections necessitated by amendment. However, the Examiner notes that according to paragraph 3 of page 8 the range of 40-100:1 (calcium-based particles to biocompatible binder), when encompasses the 100:1 (calcium-based particles to biocompatible binder) disclosed by Hu at page 8. Additionally, Safronova clearly motivates one of ordinary skill in the art to optimize the amount of biocompatible biner (PVA) with respect to the calcium based particles (hydroxyapatite). See, for example, Safronova at page 4, paragraph 2: “An increase in the PVA content from 0.25 to 0.5% makes the aggregates larger, stronger, and denser. Aggregates with high densities can be regarded as control signals.”
4) On page 8 of their remarks, Applicant argues that one would not have been motivated from Vanderploeg, even in combination with Hu, to arrive at claims 21 and 22, with a reasonable expectation of success of achieving the advantageous effects of the invention.
This argument is moot in view of the new rejections necessitated by amendment. However, the Examiner notes that the fact that the inventor 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. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612