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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/8/2025 has been entered.
Priority
This application is a national stage entry of PCT/KR2020/009933, filed 7/28/2020. This application claims foreign priority to KR10-2019-0107653, filed 8/30/2019.
Claim Status
Receipt of Remarks/Amendments filed on 12/8/2025 is acknowledged. Claims 1-10 are currently pending. Claims 1-9 have been withdrawn. Accordingly, claim 10 is currently under examination.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
New/Maintained Claim Objection(s) / Rejection(s)
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Besim et al. (Biomaterials Science and Engineering Book Series, Vol. 14, pages 51-78, July 9, 2019) (cited in IDS) in view of Lee et al. (Heliyon 5 (April 24, 2019) e01588) (cited in IDS), Goller et al. (Materials Letter 56 (2002) 142-147), Chen et al. (CN109157677A; 01-08-2019) and Albright et al. (Nature vol. 247, January 25, 1974) (cited in IDS).
Besim throughout the reference teaches marine derived biomaterials for bone regeneration and tissue engineering. The natural structures such as foraminifera are used for making bioactive bone scaffolding materials and these natural structures are converted to hydroxyapatite to assist osseointegration. (see: Title; Abstract). Besim particularly teaches preparation of bioactive bone graft wherein foraminifera shells (exoskeleton) were used to prepare hydroxyapatite. Besim teaches wherein the foraminifera is Baculogypsina sphaerulata (Fig. 3.5). The foraminifera shells were converted to a more stable hydroxyapatite using hydrothermal conversion method. The hydrothermal conversion method is performed using high temperatures (between 200 and 260 C) for a period of 24-48 hours. Besim discloses the hydroxyapatite material being internally permeated by a network of microscopic interconnected channels (i.e., chambers) measuring 1–10 μm in diameter. Moreover, nano- and meso-pores are contained between the micropores surface area. Fig. 3.5 in SEM image shows microscopic interconnected channels (chambers) on the surface separated by walls (i.e., partition walls) which have the nano- and meso-pores (i.e., plurality of pores). The foraminifera microspheres measured 0.5-1.5mm (500-1500 micrometer) in diameter, which reads on the plurality of particles and particle sizes recited in instant claim. The foraminifera microspheres were used as bioactive grafts and drug delivery devices. (see: pg. 63-64, section 3.4.2; pg. 67-68, section 3.5.2; Fig. 3.5;).
The teachings of Besim have been set forth above.
Besim does not expressly teach the method step of pretreating foraminifera as recited in claim 10 and wherein the hydroxyapatite comprises magnesium, silicon or strontium ions and the weight percent thereof as recited in claim 10 . However, Lee et al. cures these deficiencies.
Lee et al. throughout the reference also teaches synthesis of hydroxyapatite from natural sources (Title). Lee teaches hydroxyapatite from marine sources wherein pretreatment of these sources is done to remove debris/dirt before performing treatments such as hydrothermal treatment or calcination and the pretreatment can be done by rinsing in tap water followed by soaking in low concentrations of hydrochloric acid. (see: section 2.2.2. Aquatic or marine sources). Lee also teaches trace elements in hydroxyapatite are essential in the regeneration of the bone and accelerates the process of bone formation. Lee teaches 3-5% of silicon increased cell growth density which enhanced osteoblast growth and 1-10% of strontium ions enhanced osteoblast activity and differentiation and also inhibited osteoclast proliferation and production.
Besim also does not expressly teach the method step of sintering the hydroxyapatite as recited in claim 10. However, Goller cures this deficiency.
Goller throughout the reference teaches sintering effects on mechanical properties of biologically derived hydroxyapatite wherein the mechanical properties can be substantially improved by sintering (Title; Abstract). Goller discloses hydroxyapatite can be hydrothermally converted from natural sources such as coral or synthetically produced. Goller teaches the mechanical properties of hydroxyapatite are poor and that it is possible to obtain hydroxyapatite with high strength, hardness and high density by sintering for use as a graft material for bones or teeth (see: Introduction; conclusion).
While Goller teaches the method step of sintering the hydroxyapatite, the combination of the previous references do not teach the specific method steps of sintering of hydroxyapatite as recited in claim 10. However, Chen cures this deficiency.
Chen also teaches preparing a bone tissue scaffold comprising hydroxyapatite and performing sintering of the hydroxyapatite. The sintering process comprises raising the temperature to 500 to 650 C at a temperature of 1 to 3 C/min, and the temperature is maintained for 1 to 5 hours, followed by raising the temperature to 1100 to 1350 C at a temperature of 8 C/min and the temperature is maintained for 2 to 5 hours, and then cooling to room temperature. (see: summary of invention).
The teachings of Besim, Lee, Goller and Chen have been set forth above.
As discussed supra, Besim discloses the hydroxyapatite material being internally permeated by a network of microscopic interconnected channels (i.e., chambers) measuring 1–10 μm (micron) in diameter. Besim discloses microscopic interconnected channels (chambers) on the surface separated by walls (i.e., partition walls) which have the nano- and meso-pores (i.e., plurality of pores). The foraminifera microspheres measured 0.5-1.5mm (500-1500 micrometer) in diameter.
Besim, Lee, Goller and Chen do not expressly teach wherein the chamber has a diameter of 15 to 60 micron and wherein the hydroxyapatite has 40,000 to 60,000 chambers per 1 cm2 on a surface of the hydroxyapatite. However, the combination of Lee and Albright cures these deficiencies.
Lee further discusses the effect of processing method and the sources on the properties of hydroxyapatite such as size, crystallinity, morphology and phase assemblage. Lee teaches that in general, the morphology and size of the hydroxyapatite produced is dependent on the sources and the processing method. (see: Introduction; Conclusion). Lee also discloses wherein the size and morphology of the hydroxyapatite changed depending on the temperature used during processing method (see: Introduction; section 2.2.1, 2.2.2, 2.3.1, 2.3.2).
Albright also teaches hydroxyapatite formed from coral skeletal carbonate by hydrothermal exchange. Albright teaches that porous microstructures have been prepared by employing exchange reactions at elevated temperatures and pressures. Porous solids have the advantage of allowing circulation of body fluids and of increasing the potential for firm attachment of body tissue to enable regeneration. (see: page 220, left column and page 222, left column).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of the cited references and pretreat the foraminifera before performing hydrothermal reaction as suggested by Lee. As discussed supra, Lee also teaches synthesis of hydroxyapatite from natural sources. Lee teaches hydroxyapatite from marine sources wherein pretreatment of these sources is done to remove debris/dirt before performing treatments such as hydrothermal treatment or calcination and the pretreatment can be done by rinsing in tap water followed by soaking in low concentrations of hydrochloric acid. Therefore, it would have been obvious to one skilled in the art to perform pretreatment to remove debris/dirt from the foraminifera before performing hydrothermal reaction. Further, it would have been obvious to one skilled in the art to combine the teachings of Besim, Lee and Goller and include trace elements such as silicon and strontium ions and the amounts thereof in the hydroxyapatite of Besim as taught by Lee. As discussed supra, Lee teaches trace elements in hydroxyapatite are essential in the regeneration of the bone and accelerates the process of bone formation. Lee teaches 3-5% of silicon increased cell growth density which enhanced osteoblast growth and 1-10% of strontium ions enhanced osteoblast activity and differentiation and also inhibited osteoclast proliferation and production. As discusses supra, Besim also teaches the marine derived biomaterials used for bone regeneration and tissue engineering. Therefore, one skilled in the art would have been strongly motivated to include the trace elements taught by Lee in the hydroxyapatite of Besim.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of the cited references and perform the method step of sintering the hydroxyapatite as taught by Goller. As discussed supra, Goller teaches sintering effects on mechanical properties of biologically derived hydroxyapatite wherein the mechanical properties can be substantially improved by sintering. Goller discloses hydroxyapatite can be hydrothermally converted from natural sources such as coral or synthetically produced. Goller teaches the mechanical properties of hydroxyapatite are poor and that it is possible to obtain hydroxyapatite with high strength, hardness and high density by sintering for use as a graft material for bones or teeth. As discusses supra, Besim also teaches the marine derived biomaterials used for bone regeneration and tissue engineering. Therefore, one skilled in the art would have been strongly motivated to sinter the hydroxyapatite of Besim to obtain a bone graft material which provides high strength, hardness and density.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of the cited references and sinter the hydroxyapatite using the method steps taught by Chen. As discussed supra, Goller already provides the motivation to perform a sintering of the hydroxyapatite and Chen further teaches the specific method steps known in the art to perform the sintering of the hydroxyapatite. Therefore, it would have been obvious to one skilled in the art to further incorporate the teachings of Chen and utilize the method steps of sintering hydroxyapatite as taught by Chen. Further, Chen discloses the second state of sintering constitutes raising the temperature to 1100 to 1350 C and the instant claims recite raising the temperature of hydroxyapatite to 800 C. However, as discussed supra, Goller teaches the mechanical properties of hydroxyapatite are poor and that it is possible to obtain hydroxyapatite with high strength, hardness and high density by sintering for use as a graft material for bones or teeth. Thus, it would have been prima facie obvious to one skilled in the art to experiment and determine the optimal temperature which provides hydroxyapatite having the desired strength, hardness and density for use as a graft material. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of the cited references and manipulate the processing method (e.g., temperature during hydrothermal treatment or sintering) to obtain hydroxyapatite with the desired number of interconnected channels (i.e., chambers) and the size thereof along with the particle sizes as suggested by Lee and Albright. One would have been motivated do so because, as discussed supra, Lee teaches that in general, the morphology and size of the hydroxyapatite produced is dependent on the sources and the processing method such as temperature. Albright teaches that porous microstructures have been prepared by employing exchange reactions at elevated temperatures and pressures. Porous solids have the advantage of allowing circulation of body fluids and of increasing the potential for firm attachment of body tissue to enable regeneration. Thus, it would have been obvious to one skilled in the art manipulate the process method such as the temperature to obtain a hydroxyapatite with a specific number of channel (chambers) and the claimed sizes to produce a bioactive graft that provides optimal bone regeneration. Further, as discussed surpa, Besim discloses the hydroxyapatite material being internally permeated by a network of microscopic interconnected channels (i.e., chambers) measuring 1–10 μm (micron) in diameter. A diameter of 10 micron is merely close to 15 microns recited in the instant claims and a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). See: MPEP 2144.05(I). Additionally, the combination of the cited prior art renders obvious all the method steps recited in the instant claim and therefore, the resulting hydroxyapatite formed would necessarily comprise all the characteristics and properties (e.g., size and morphology) recited in the instant claim. Based on the substantially identical process using identical components, the Examiner has a reasonable basis to believe that the properties claimed in the present invention are inherent in the composition disclosed by the cited prior art. Because the PTO has no means to conduct analytical experiments, the burden of proof is shifted to the Applicant to prove that the properties are not inherent. ““[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).” MPEP § 2112, I.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant's arguments, filed 12/8/2025, with respect to the 103 rejections have been fully considered but they are not persuasive.
Applicant argued that the Examples demonstrate that the hydroxyapatite prepared from foraminifera exhibits specific compositional characteristics (Mg, Si, and Sr contents, see Table 1 of the as-filed specification), as well as distinctive chamber and pore structures (see paragraphs [00221-[00241 of the as-filed specification). The experimental results further confirm that the hydroxyapatite of the present application provides enhanced osteogenic differentiation, improved cell adhesion, and superior in vivo bone regeneration. In the amended claim 10, the physical and chemical characteristics of the hydroxyapatite derived from foraminifera have been further clarified and specifically defined. These characteristics arise from the inherent microstructure and chemical composition of foraminifera, which differ substantially from those of other natural or synthetic precursors. (see section 1 of applicant remarks: Technical features of the present application; Also see section 3 of applicant remarks).
In response, as discussed in the rejection above, the cited prior art renders obvious the claimed compositional characteristics (Mg, Si, and Sr contents) as well as the chamber and pore structures recited in the instant claims. Also, as mentioned above, the combination of the cited prior art renders obvious all the method steps recited in the instant claim and therefore, the resulting hydroxyapatite formed would necessarily comprise all the characteristics and properties (e.g., size and morphology) recited in the instant claim. Regarding the argument that the experimental results further confirm that the hydroxyapatite of the present application provides enhanced osteogenic differentiation, improved cell adhesion, and superior in vivo bone regeneration, the examiner in response argues that applicant have not provided any persuasive evidence or experimental data which show that the hydroxyapatite of the present application provides enhanced osteogenic differentiation, improved cell adhesion, and superior in vivo bone regeneration. “The arguments of counsel cannot take the place of evidence in the record.” In re Schulze, 346 F.2d 600, 145 USPQ 716, 718 (CCPA 1965), In re Huang, 40 USPQ 2d 1685 (Fed. Cir. 1996), In re De Blauwe et al., 222 USPQ 191, (Fed. Cir. 1984). Applicant has not provided any factual evidence establishing that the hydroxyapatite of the present application provides enhanced osteogenic differentiation, improved cell adhesion, and superior in vivo bone regeneration compared to the prior art. Further, as applicant acknowledge that these characteristics arise from the inherent microstructure and chemical composition of foraminifera, the examiner reiterates that the combination of the cited prior art renders obvious all the method steps recited in the instant claim and therefore, the resulting hydroxyapatite formed would necessarily comprise all the characteristics and properties (e.g., size and morphology) recited in the instant claim.
Applicant argued that Besim, Lee Goller, Chen and Albright disclose distinct material origins, microstructures, compositions and processing parameters and therefore do not provide any motivation to combine multiple parameters as recited in the amended claim 10. It was argued that each cited reference discloses only fragmentary aspects of the subject matter of amended claim 10 and a specific motivation to combine multiple cited reference must be demonstrated to establish a prima facie case of obviousness. (see section 2 of applicant remarks: Cited References; also see section 3 of applicant remarks).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
As discussed in detail in the 103 rejection above, Lee teaches synthesis of hydroxyapatite from natural sources. Lee teaches hydroxyapatite from marine sources wherein pretreatment of these sources is done to remove debris/dirt before performing treatments such as hydrothermal treatment or calcination and the pretreatment can be done by rinsing in tap water followed by soaking in low concentrations of hydrochloric acid. Therefore, it would have been obvious to one skilled in the art to perform pretreatment to remove debris/dirt from the foraminifera before performing hydrothermal reaction. Further, it would have been obvious to one skilled in the art to combine the teachings of Besim, Lee and Goller and include trace elements such as silicon and strontium ions and the amounts thereof in the hydroxyapatite of Besim as taught by Lee. Lee teaches trace elements in hydroxyapatite are essential in the regeneration of the bone and accelerates the process of bone formation. Lee teaches 3-5% of silicon increased cell growth density which enhanced osteoblast growth and 1-10% of strontium ions enhanced osteoblast activity and differentiation and also inhibited osteoclast proliferation and production. Besim also teaches the marine derived biomaterials used for bone regeneration and tissue engineering. Therefore, one skilled in the art would have been strongly motivated to include the trace elements taught by Lee in the hydroxyapatite of Besim.
Goller teaches sintering effects on mechanical properties of biologically derived hydroxyapatite wherein the mechanical properties can be substantially improved by sintering. Goller discloses hydroxyapatite can be hydrothermally converted from natural sources such as coral or synthetically produced. Goller teaches the mechanical properties of hydroxyapatite are poor and that it is possible to obtain hydroxyapatite with high strength, hardness and high density by sintering for use as a graft material for bones or teeth. Besim also teaches the marine derived biomaterials used for bone regeneration and tissue engineering. Therefore, one skilled in the art would have been strongly motivated to sinter the hydroxyapatite of Besim to obtain a bone graft material which provides high strength, hardness and density.
Goller already provides the motivation to perform a sintering of the hydroxyapatite and Chen further teaches the specific method steps known in the art to perform the sintering of the hydroxyapatite. Therefore, it would have been obvious to one skilled in the art to further incorporate the teachings of Chen and utilize the method steps of sintering hydroxyapatite as taught by Chen. Further, Chen discloses the second state of sintering constitutes raising the temperature to 1100 to 1350 C and the instant claims recite raising the temperature of hydroxyapatite to 800 C. However, Goller teaches the mechanical properties of hydroxyapatite are poor and that it is possible to obtain hydroxyapatite with high strength, hardness and high density by sintering for use as a graft material for bones or teeth. Thus, it would have been prima facie obvious to one skilled in the art to experiment and determine the optimal temperature which provides hydroxyapatite having the desired strength, hardness and density for use as a graft material. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Finally, it would have been obvious to combine the teachings of the cited references and manipulate the processing method (e.g., temperature during hydrothermal treatment or sintering) to obtain hydroxyapatite with the desired number of interconnected channels (i.e., chambers) and the size thereof along with the particle sizes as suggested by Lee and Albright. One would have been motivated do so because, as discussed supra, Lee teaches that in general, the morphology and size of the hydroxyapatite produced is dependent on the sources and the processing method such as temperature. Albright teaches that porous microstructures have been prepared by employing exchange reactions at elevated temperatures and pressures. Porous solids have the advantage of allowing circulation of body fluids and of increasing the potential for firm attachment of body tissue to enable regeneration. Thus, it would have been obvious to one skilled in the art manipulate the process method such as the temperature to obtain a hydroxyapatite with a specific number of channel (chambers) and the claimed sizes to produce a bioactive graft that provides optimal bone regeneration. Further, as discussed surpa, Besim discloses the hydroxyapatite material being internally permeated by a network of microscopic interconnected channels (i.e., chambers) measuring 1–10 μm (micron) in diameter. A diameter of 10 micron is merely close to 15 microns recited in the instant claims and a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). See: MPEP 2144.05(I). Additionally, the combination of the cited prior art renders obvious all the method steps recited in the instant claim and therefore, the resulting hydroxyapatite formed would necessarily comprise all the characteristics and properties (e.g., size and morphology) recited in the instant claim. Based on the substantially identical process using identical components, the Examiner has a reasonable basis to believe that the properties claimed in the present invention are inherent in the composition disclosed by the cited prior art. Because the PTO has no means to conduct analytical experiments, the burden of proof is shifted to the Applicant to prove that the properties are not inherent. ““[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).” MPEP § 2112, I.
Therefore, applicant’s argument that the cited references disclose distinct subject matter and do not provide motivation to combine multiple parameters recited in the claim is not persuasive because the rejection clearly explains the reasons for obviousness to combine the teachings of the cited references.
Applicant again argued that the claimed invention provides a method of producing hydroxyapatite that reflects the inherent microstructure and composition unique to foraminifera, and has the remarkable technical effects-including enhanced osteogenic differentiation, improved cell adhesion, and superior in vivo bone regeneration-resulting from the features as recited in the amended claim 10. The properties of hydroxyapatite vary significantly depending on factors such as the biological origin of the raw material, its inherent microstructure, and its crystallinity. The claimed invention is based on the synergistic and interdependent combination of multiple parameters, including the use of foraminifera as a specific natural precursor, defined sintering conditions, defined compositional ranges, and specific structural and microstructural features. (see section 3 and 4 of applicant remarks).
In response, as discussed in the 103 rejection, Besim expressly teaches producing hydroxyapatite from foraminifera wherein foraminifera is Baculogypsina sphaerulata. Thus, the primary reference, Besim, teaches the same raw material as claimed which is used to produce the hydroxyapatite. As discussed supra, the method steps producing the hydroxyapatite from foraminifera as claimed is also taught and rendered obvious by the combination of the cited prior art reference. While applicant argue of synergistic and unexpected effects, applicant have not provided any persuasive evidence to show that the claimed method of producing the bone graft material has unexpected effects which are not taught in the prior art. “The arguments of counsel cannot take the place of evidence in the record.” In re Schulze, 346 F.2d 600, 145 USPQ 716, 718 (CCPA 1965), In re Huang, 40 USPQ 2d 1685 (Fed. Cir. 1996), In re De Blauwe et al., 222 USPQ 191, (Fed. Cir. 1984). Applicant has not provided any factual evidence establishing that the hydroxyapatite of the present application provides enhanced osteogenic differentiation, improved cell adhesion, and superior in vivo bone regeneration compared to the prior art. Further, as applicant acknowledge that these characteristics arise from the inherent microstructure and chemical composition of foraminifera, the examiner reiterates that the combination of the cited prior art renders obvious all the method steps recited in the instant claim and therefore, the resulting hydroxyapatite formed would necessarily comprise all the characteristics and properties (e.g., size and morphology) recited in the instant claim.
Conclusion
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/ALI S SAEED/Examiner, Art Unit 1616