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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/18/2026 has been entered.
Applicants’ arguments, filed 05/18/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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, 3-10, 12-14, 18-20 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.
The term “calcium-based” in claim 1 is a relative term which renders the claim indefinite. The term “calcium-based” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what is meant by this term such that the artisan would reasonably appreciate the metes and bound of what is encompassed by it. It is not clear how far from the base particle one can deviate and still meet the requirement of the claim. For example, it is not clear what percent of the particle must be calcium for the particle to be “calcium-based”. For the purposes of examination this will be interpreted as a particle comprising calcium.
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, 3-5, 12, 14, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (CN 108114316 A, publication date 05/06/2018; citing English machine translation; previously cited) in view of Kapoor et al. (AIP Conf. Proc. 1393, 2011, 375-376; previously cited).
Hu discloses a ceramic-based dental bone powder with excellent bone repair effect and low production cost which comprises porous hydroxyapatite (i.e., instant claim 12) and type 1 collagen (i.e., biodegradable carrier) [abstract]. Specifically, the composition comprises 1-10% porous hydroxyapatite and I-type collagen [p. 2, last quarter of the page]. 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 does not disclose the heat treatment as instantly claimed.
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].
In regard to the process of heat treatment, 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 Hu desires particles of hydroxyapatite while Kapoor discloses that beta-tricalcium phosphate begins to form at 1200 deg. C and that hydroxyapatite is stable up to 1000 deg. C. One would have had an expectation of success because according to Kapoor the heat treated hydroxyapatite particles disclosed therein are suitable for tissue engineering. Additionally, in making this modification, one would have expected nothing more than predictable results. See MPEP 2143, Exemplary Rationale C.
In regard to the process of spray-drying composite particles and a biocompatible binder, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP 2113.). In this case, the prior art product appears to be the same or obvious as claimed, despite not teaching the claimed spray-drying steps, insofar as the particles of Hu are calcium-based sintered porous particles. Additionally, the biocompatible binder of the claimed methods is not present in the instantly claimed composition, as evidenced by the instant specification at page 15, paragraph 2 (“500°C for 2 hours in a box furnace to remove PVA”).
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 1-50 parts inorganic particles to 100 parts carrier (i.e., instant claim 14) overlaps with the range of the prior art (10:90 inorganic particles to carrier; about 11:100 inorganic particles to carrier) and so a prima facie case of obviousness exists. Additionally, the instantly claimed range for the first phase of the heat treatment, 450-550 deg C, overlaps with the range of the prior art, 500-600 deg. C and so a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a composition, and product, comprising a porous sintered inorganic calcium-based particle (hydroxyapatite) and a biodegradable carrier. Wherein the particle is heat treated as instantly claimed. Wherein the inorganic particle (hydroxyapatite) and carrier are present within the instantly claimed ratios. 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 of Equations 1 and 2 of instant claims 1 and 3.
2) Claims 1, 3-9, 12-14, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al. (Soft Tissue and Materials, 2016, v. 31, n. 3, p. 464-474) in view of Kapoor et al. (AIP Conf. Proc. 1393, 2011, 375-376; previously cited), Capistron et al. (US 2013/0060230 A1, publication date 03/07/2013), Wang et al. (Journal of Biomedical Materials Research Part A, 2008, p. 557-562) and Bastan et al. (Materials and technology, 2013, vol. 47, issue 3, pages 303-306; previously cited).
Regarding instant claims 1, 3-6, 12, 13, 19 and 20, in Jeong Hyaluronic acid (HAc)–hydroxyapatite (HAp) (i.e., instant claims 12-13) “composite hydrogels were developed to improve the biostability and bioactivity of HAc for dermal filler applications” [abstract]. Specifically, “Two kinds of HAc-HAp composite fillers were generated: HAcmicroHAp and HAc-nanoHAp composites” (i.e., hydroxyapatite particles in contact with and dispersed inside or outside the biodegradable carrier; instant claims 4 and 5) [abstract]. For HAc-microHAp filler preparation, Hap microspheres were prepared by spray-drying a solution consisting of HAp powder, PVB, and KD6, followed by heat treatment at 500 [deg] C for 2 h and 1200[deg]C for 2h” (i.e., spray-drying; instant claim 19) [p. 465, col. 2, para. 2, lines 9-12].
Jeong does not disclose a heat treatment between 600 deg C and 1000 deg C. Jeong also does not explicitly teach porous particles and the instantly claimed range of biocompatible binder to particles in the spray drying step.
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].
Capistron relates to a soft tissue filler “comprising calcium phosphate particles having a porosity of about 10% to about 90%, a BET surface area of about 1 m/g to about 100 m/g, and a mean particle size of about 1 micron to about 30 microns” [abstract]. “Desirably the calcium phosphate particles are selected from a group consisting of hydroxyapatite” [0015] and “the calcium phosphate particles are partially or fully sintered particles” [0016]. “The properties of the calcium phosphate particles (e.g., crystal size, particle size, surface area and porosity) desirably are selected so as to provide the highest occluded volume per unit mass while resisting collapse of the particle matrix or scaffolding” [0027]. “The calcium phosphate particles are further characterized by a mean particle size of […] more preferably about 2 microns to about 10 microns” and that “about 95% or more, of the particles are within the desired particle size range” (i.e., maximum particle size) [0019].
Wang “deals with the effect of sintering temperature on the physical and chemical characteristics of hydroxyapatite microspheres (HAMs) obtained by spray drying method” [abstract]. According to Wang “When the samples were sintered at the temperature of 500 and 600[deg]C, no obvious changes can be found on the surfaces of the samples, but at 800[deg]C, open-micropore surfaces came forth” [abstract]. For example see Table II in column 2 of page 558 of Wang, reproduced below:
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228
564
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Greyscale
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.]. According to Bastan, “[t]he PVA affected only the particle size. After the particle size analysis, it was seen that the particle size increases with increasing PVA addition for a good binding” [p. 305, sentences spanning col.1 and 2].
In regard to the heat treatment, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have modified the methods of Jeong 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 Jeong desires particles of hydroxyapatite and Kapoor discloses that beta-tricalcium phosphate begins to form at 1200 deg. C and that hydroxyapatite is stable up to 1000 deg. C. One would have had an expectation of success because according to Kapoor the heat treated hydroxyapatite particles disclosed therein are suitable for tissue engineering. Additionally, in making this modification, one would have expected nothing more than predictable results. See MPEP 2143, Exemplary Rationale C.
In regard to the particle porosity, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formed the hydroxyapatite particles of Jeong to have a total pore volume within the instantly claimed range 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 pore volume of the particles disclosed by Jeong to provide the optimal occluded volume per unit mass while resisting collapse of the particle matrix or scaffolding, as taught by Capistron. One would have had an expectation of success because Wang discloses methods for adjusting the total pore volume of spray dried and sintered hydroxyapatite particles.
In regard to the particle to binder ratio, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a composition according to Jeong wherein the spray drying step comprises hydroxyapatite particles and a biocompatible binder within the instantly claimed ratios 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 hydroxyapatite to binder ratio of the spray drying disclosed by Jeong to reach optimal particles size with respect to total occluded volume per mass as taught by Capistron. One would have had an expectation of success because Bastan disclosed the amount binder (i.e., PVA) effects the size of spray dried hydroxyapatite particles.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a composition (i.e., product; instant claim 20) comprising porous inorganic particles including a sintered body of calcium-based particles and pores distributed in the sintered body (i.e., porous hydroxyapatite) and a biodegradable carrier (i.e., hyaluronic acid). Wherein the particles are spray dried with a biocompatible binder (i.e., PVA) and heat treated as instantly claimed. Wherein the porous hydroxyapatite particles are in contact with, and dispersed inside or outside, the biodegradable carrier. Wherein the particles have total pore volume within the range of instant claim 6. 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 of Equations 1 and 2 of instant claims 1 and 3.
Regarding instant claim 7, according to Capistron, preferably the surface area is 1-20 m2/g [0024].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have modified the sintered hydroxyapatite particles of Jeong to have the specific surface area described by Capistron by the methods disclosed by Wang. One would have been motivated to modify Jeong because Capistron discloses specific surface areas that are desirable for soft tissue filler particles, e.g., sintered hydroxyapatite particles, which is the desired application of Jeong. One would have had an expectation of success because Wang disclosed methods to adjust the specific surface area of spray-dried and sintered hydroxyapatite particles. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
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 6-10 sqr. m/g overlaps with the range of the prior art 1-20 sqr. m/g and so a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the composition as discussed above, wherein the particles have a specific surface area within the instantly claimed range.
Regarding instant claims 8, 9 and 18, “The calcium phosphate particles are further characterized by a mean particle size of […] more preferably about 2 microns to about 10 microns” and that “about 95% or more, of the particles are within the desired particle size range” (i.e., maximum particle size) [0019].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have modified the sintered hydroxyapatite particles of Jeong to have a maximum particle size described by Capistron by the methods disclosed by Bastan. One would have been motivated to modify Jeong because Capistron discloses preferred particle sizes for soft tissue fillers, e.g., sintered hydroxyapatite particles, the desired application of Jeong. One would have had an expectation of success because Bastan disclosed binder concentration during spray-drying effects particle size of hydroxyapatite particles. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
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 ranges for maximum particle size (i.e., 1-1000 microns, 10nm -10 microns, and 1-100 microns; instant claims 8, 9 and 18) overlap with the range of the prior art (1-30 microns, preferably 2-10 microns) and so a prima facie case of obviousness exists.
Regarding instant claim 14, in one example of the synthesis Jeong discloses “30 wt% nanoHAp within the [hyaluronic acid] hydrogel” [p. 465, col. 2, para. 2, penultimate sentence].
Capistron discloses that “The amount of carrier present in the filler composition of the invention can vary, and is selected so as to achieve the desired viscosity of the composition. Typically the filler composition contains about 1% to about 70% by weight carrier” [0044].
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 weight ratio of porous inorganic particles to biodegradable carrier (i.e., 1-50 to 100) overlaps with the prior art (e.g., 30% w/w porous inorganic particles in hyaluronic hydrogel; 30:70 porous inorganic particles to hyaluronic hydrogel; about 43:100 porous inorganic particles to hyaluronic hydrogel) and so a prima facie case of obviousness exists.
3) Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al. (Soft Tissue and Materials, 2016, v. 31, n. 3, p. 464-474) in view of Kapoor et al. (AIP Conf. Proc. 1393, 2011, 375-376; previously cited), Capistron et al. (US 2013/0060230 A1, publication date 03/07/2013), Wang et al. (Journal of Biomedical Materials Research Part A, 2008, p. 557-562) and Bastan et al. (Materials and technology, 2013, vol. 47, issue 3, pages 303-306; previously cited) as applied to claims 1, 3-9, 12-14, 18-20 above, and further in view of Groot-Barrere et al. (NL 2011195 C2, publication date 01/21/2015; previously cited).
Jeong, Kapoor, Capistron, Wang and Bastan, which are taught above, differ from the instant claims insofar as they do not teach acicular particles. Jeong discloses the particle sizes of 200nm [p. 467, col. 1, para. 1, last sentence]. Jeong also discloses that “nanoHAp particles have better effects on ECM stimulation than microHAp over a longer period of time owing to their larger surface area exposed to the dermal environment” [p. 471, col. 2, second sentence].
Capistron discloses that “[h]igh surface area is desirable to bind various proteins secreted by the surrounding tissue, thus strengthening the scaffold by encouraging connective tissue ingrowth” [0024].
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 Jeong as needle-like particles because Groot-Barrere discloses it improves surface area and pore volume. One would have been motivated to improve surface area because Jeong and Capistron teach high surface area particles are desirable for soft tissue fillers. One would have has an expectation of success because Groot-Barrere discloses grain-like particles of a similar size to Jeong 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, before the effective filling date of the claimed invention, to have the compositions taught by Jeong, Kapoor, Capistron, Wang and Bastan, as discussed above, to comprise acicular particles within the instantly claimed size range.
Response to Arguments
1) On pages 11 and 12 of their Remarks, Applicant argues that Hu fails to teach the instantly claimed range of inorganic particle to binder during the spray drying step.
This argument is not persuasive. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP 2113.). In this case, the prior art product appears to be the same or obvious as claimed, despite not teaching the claimed spray-drying steps, insofar as the particles of Hu are calcium-based sintered porous particles. Additionally, the biocompatible binder of the claimed methods is not present in the instantly claimed composition, as evidenced by the instant specification at page 15, paragraph 2 (“500°C for 2 hours in a box furnace to remove PVA”).
Furthermore, this argument is moot in view of rejections 2) and 3), based on Jeong as the primary reference.
2) On pages 11 and 12 of their Remarks, Applicant argues that the prior art does not teach the instantly claimed bioactivity.
This argument is not persuasive. Since the prior art composition contains substantially the same components, i.e., porous inorganic particles and biodegradable carrier, in the same relative proportions as instantly claimed, it would be expected to inherently possess the same chemical and physical properties, such as having the bioactivity of Equations 1 and 2 of instant claims 1 and 3. “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.” MPEP2112.02 (II).
3) On pages 13 and 14 of their Remarks, Applicant alleges that the instantly claimed particle to binder ratio has unexpected bioactivity according to Equation 1. Applicant cites Examples 1 and 2 of the instant specification.
This argument is not persuasive. First, the specification does not identify the instantly claimed range for the ratio of particle to binder in the spray drying step to be responsible for any unexpected results regarding bioactivity. Rather the specification discloses that when the ratio controls the particle strength and low particle strength “makes it difficult [for particles] to maintain the shape, and the shape of the particles may be distorted” [instant specification, page 8, para. 1]. This effect of polymer binders on spray dried particles was recognized by the prior art. See for example Stunda-Zujeva et al. (Ceramics International, 2017. Volume 43, Issue 15, Pages 11543-11551). Stunda-Zujeva discloses “Binder is usually used to improve the mechanical strength of granules, to increase the elasticity of granules and to create composites; alternatively the binder can be burned out by thermal treatment afterwards to obtain larger surface area of the granules” [p. 11548, col. 1, paragraph 1 of Section 4.4].
Secondly, Overcoming a rejection based on unexpected results requires the combination of three different elements: (i) the results must fairly compare with the prior art, (ii) the results must truly be unexpected and (iii) the claims must be commensurate in scope. MPEP §716.02. The burden rests with Applicant to establish results are unexpected and significant. MPEP §716.02(b). Applicant's showing of allegedly unexpected results does not satisfy any of these requirements.
(i) Applicant has not compared the instantly claimed composition to the closest prior art which is disclosed by Jeong et al.
(ii) To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). (MPEP 716.02(d)). In the present case, applicant has provided example with a HAp/PVA (particle to binder) ratio of 12/1 (Examples 1 and 2) and Examples 3-5 (pages 15-16) discloses ratios of 50/1 and 80/1. Applicant has not provided any objective evidence with ratios below the instantly claimed range. Furthermore, it is unclear how one ratio of 12:1 (particle to binder) reasonably represent the entire claimed range (5-30:1 particle:binder). It is also unclear how the criticality of the 30/1 ratio is established based on the showing that compositions spray dried with the ratios 50/1 and 80/1 do not meet the claimed bioactivity.
Accordingly, the Examiner is not able to determine the criticality of the instantly claimed range.
Furthermore, the results do not appear to be truly unexpected in view of the prior art. Stunda-Zujeva discloses “Binder is usually used to improve the mechanical strength of granules, to increase the elasticity of granules and to create composites; alternatively the binder can be burned out by thermal treatment afterwards to obtain larger surface area of the granules” [p. 11548, col. 1, paragraph 1 of Section 4.4]. According to Jeong, larger surface area means better effects on ECM stimulation (i.e., bioactivity) [p. 471, col. 2]. Additionally, a skilled artisan would have understood that particles with large surface area have more opportunities to interact with the environment around them. Therefore, a skilled artisan would have expected that calcium-based particles with larger surface areas would have had a larger impact on the calcium ions in the environment around them.
(iii) The "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support" (see MPEP 716.02(d) quoting In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)). In the present case the claims are not commensurate in scope because the narrow showing of hydroxyapatite particles does not reasonably represent every calcium based particle, as instantly claimed. Additionally, the independent claim does not recite spray drying which, according to the instant examples, is important to the alleged impact of the particle to binder ratio. The independent claims also does not recite particle size and Examples 1 and 2 demonstrate that particle size effects bioactivity (see Tables, 1 and 2, pages 18 and 19). Finally, it is also unclear how Examples 1 and 2, which only recite acicular particles, reasonably represent all particle shapes in view of Groot-Barrere (needle-like particle shape is associated with an increase in specific surface area and pore area [p. 3, lines 16-18]).
4) On pages 14-17 of their Remarks, Applicant argues that the secondary references of the previous office action fail to remedy the alleged deficiencies of Vanderploeg.
These arguments are moot in view of the new rejections set forth above.
Conclusion
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/C.T.W./ Examiner, Art Unit 1612
/WALTER E WEBB/ Primary Examiner, Art Unit 1612
Prosecution Insights