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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22 Jul 2026 has been entered.
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 22 Jul 2026 has been entered.
Claims 16-20 and 22-35 remain pending in the application.
Claims 16, 20, and 22 are amended.
Claim 1-15 and 21 are cancelled.
Claims 27-30 and 33-35 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 16-20, 22-26, 31 and 32 are under consideration to the extent of the elected species, i.e., that the pharmaceutically acceptable carrier is glycerol.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 103
The rejection of claims 22 under 35 U.S.C. 103 as being unpatentable over Capistron et al. (US 2013/0060230, 07 Mar 2013) as evidenced by the instant specification is withdrawn in light of applicant’s amendment of the claims, and in favor of the new grounds of rejection set forth below.
Rejections Maintained
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
The rejection below has been modified to address the new claim amendments.
Claims 16-20, 23-26, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Capistron et al. (US 2013/0060230, 07 Mar 2013) as evidenced by the instant specification.
Capistron teaches a biocompatible injectable filler composition, such as a dermal filler or sub-dermal filler composition, methods for their preparation, and a method of its use in aesthetic medical applications such as tissue augmentation and restoration ([0002]). Capistron teaches that the form of calcium phosphate particles may be hydroxyapatite ([0015]) and Capistron teaches that the particles are sintered so as to impart improved mechanical robustness and are typically treated at a temperature of about 800°C to 1200°C such as about 900°C to about 1100°C, about 950°C to about 1050°C or about 1000°C in order to crystallize and partially sinter the crystals to obtain mechanical robustness ([0016]). It is noted that the sintering temperatures taught by Capistron encompass claimed temperature of 970°C and Capistron does not require sintering at a high temperature and thus the limitation that the particles are not subjected to a temperature of more than 995°C is obvious. Capistron teaches a mean particle size of about 1 micron to about 30 microns, as determined by laser scatter ([0019]), rendering obvious the particle diameter of not more than 75 micrometers.Thus, the calcium hydroxyapatite particles sintered from about 900°C to about 1100°C and with a particle size of 1 micron to about 30 microns, renders obvious the sintered calcium hydroxyapatite particles of claim 16.
Capistron teaches that the particles are spheroidal particles having an aspect ratio of 1:1 to 5:1 so as to reduce abrasion and irritation upon injection ([0018]), rendering obvious claims 17 and 31. The aspect ratio of 1:1 to 5:1 is understood to render obvious the D-ratio above 0.7 as in claim 32. Capistron teaches that the particles are porous ([0017]), rendering obvious claim 18. Capistron teaches an example where hydroxyapatite is heated at 1000°C for 2 hours ([0109]).
Capistron teaches that the injectable tissue filler composition comprises about 10%-75% calcium phosphate particles, based on the weight of the filler composition, about 0.5%-50% thermoreversible gelling agent and water and a buffering agent ([0008]). Capistron teaches the inclusion of about 0.5 to about 10% lubricant such as glycerol (i.e. the elected species of carrier) ([0042]). The 10-75% calcium phosphate and 0.5 to 10% lubricant renders obvious the injectable compositions of claims 23-26.
Capistron does not expressly teach spherical shapes, the pore diameter, the sintering temperatures, and the composition components with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have formed a biocompatible injectable filler composition with calcium phosphate particles of hydroxyapatite from 1-30 microns and from 10-75% and glycerol from 0.5 to 10%, where spherical porous particles were formed by sintering at about 800°C to 1200°C such as about 900°C to about 1100°C, about 950°C to about 1050°C or about 1000°C. One of ordinary skill in the art would have been motivated to do so sintered calcium phosphate particles such as hydroxyapatite are taught by Capistron as suitable for biocompatible injectable filler compositions. One of ordinary skill in the art would have a reasonable expectation of successfully forming an injectable filler composition as taught by Capistron since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Regarding the pore size of claim 19, this is a feature that would necessarily be present in the sintered hydroxyapatite particles taught by Capistron. The instant specification indicates that the formation of pores is temperature dependent as particles sintered at 970°C had pores whereas particles sintered at 1170°C were essentially smooth (page 23 lines 9-11) and Fig 4B indicates pores with nanometer size. Sintering hydroxyapatite particles at lower temperatures such as 970°C is obvious from the teachings of Capistron and the resulting particles would thus necessarily have pores with sizes that render obvious claim 19. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Capistron.
Response to Arguments
Applicant's arguments filed 22 Jul 2026 have been fully considered but they are not persuasive. Applicant states that the purpose of Capistron is adding bulk to the area of injection to restore or increase soft tissue volume and that Capistron teaches adding additional collagen as an additive to the filler which implies that stimulation of collagen is not intended and that Capistron is silent with respect to fibroblast cells, collagen expression and any biostimulatory effect associate with sintering temperature (page 7 of remarks). Applicant argues that Capistron does not disclose sintering at 970 °C and does not teach a particle diameter limitation of not more than 75 μm and does not teach that any particular sintering temperature produces a collagen biostimulatory effect in fibroblast cells (page 7 of remarks). Applicant notes that the example of Capistron is sintered at 1000 °C which exceeds the claimed temperature of 970 °C (page 7 of remarks). Applicant argues for unexpected results by looking to examples 2 and 3 and figures 5 and 10 which indicate improved stimulation of collagen I and III expression with particles sintered at 970 °C instead of 1070 °C or 1170 °C (page 8 of remarks).
The examiner is not persuaded by these arguments and notes that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) ("One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings."). Capistron may not teach an improvement of collagen stimulation when sintering at 970 °C but, as noted in the rejection, it is obvious from the teachings of Capistron to form particles sintered at 970 °C and that are from about 1 micron to about 30 microns.
Regarding the argument that Capistron does not disclose sintering at 970 °C and does not teach a particle diameter limitation of not more than 75 μm, the examiner notes that the rejection with Capistron was made under 35 U.S.C. 103 which requires that “a patent for a claimed invention may not be obtained… if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been prima facie 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.” “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At, 82 USPQ2d at 1396. While Capistron may not provide a specific embodiment of the instantly claimed invention, the examiner maintains that the invention as claimed is nonetheless made obvious over Capistron et al. Capistron teaches various sintering temperatures such as from about 900°C to about 1100°C ([0016]) and a mean particle size of about 1 micron to about 30 microns ([0019]). These parameters overlap with the parameters of the instant claims and are understood to present a prima facie case of obviousness for such limitations. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
As for the purported unexpected results, the examiner does not find this persuasive at least for the reasons that the results are not commensurate in scope with the claims, it is not clear that the results are truly unexpected, and it does not appear that a comparison to the closest prior art has been made. The data pointed to by the applicant shows results for sintering at 970 °C, 1070 °C, and 1170 °C for various particle sizes (examples 2 and 3, Figs 5 and 10). The data demonstrates increased collagen expression for various particle sizes sintered at 970 °C in comparison to sintering at 1070 °C or 1170 °C and the claims now recite a sintering temperature of 970 °C and a particle size of not more than 75 micrometers. However, in addition to particle size and temperature other parameters such as sintering time, the sintering atmosphere and the heating rate are important to control when sintering and it is expected that variations in such parameters would lead to variations in the properties of the calcium particles formed and thereby lead to varying collagen expression from the particles. These alternative parameters are not limited in the claims and no results have been presented or discussion made as to why the purported unexpected results would be expected for any change in these parameters. Thus, the claim for unexpected results is not reasonably expected across the wide breadth of the claims. Further, it is difficult to asses from the data presented whether the results are truly unexpected or merely a matter of routine optimization that one of ordinary skill may be expected to determine. The claims are directed to a single sintering temperature of 970 °C with no excursions above 995 °C and data is presented for particles sintered at 970 °C, 1070 °C and 1170 °C. That is a hundred degree difference between the data points tested which is a significant amount for sintering temperatures. Is the improvement in collagen expression merely a steady trend that would be observed as the sintering temperature is varied between 970 °C and 1070 °C and does the improved collagen expression occur at temperatures less than 970 °C or is there something truly unexpected that occurs at the 970 °C sintering temperature? The data is insufficient for clearly answering these questions and assessing whether the results are truly unexpected. Similarly, Capistron teaches an example where 1-10 micron hydroxyapatite is heated at 1000°C for 2 hours ([0109]). This is closer to the claimed value of 970°C than the 1070°C and 1170°C shown in the comparative data and there is nothing to indicate that the claimed particles would have any different performance than the particles formed by Capistron. Thus, overall the data presented is insufficient to overcome the prima facie case of obviousness from the teachings of Capistron.
New Grounds of Rejections
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Capistron et al. (US 2013/0060230, 07 Mar 2013) as evidenced by the instant specification as applied to claims 16-20, 23-26, 31 and 32 above and in view of Cox et al. (Key Engineering Materials, Online: 2005-04-15, ISSN: 1662-9795, Vols. 284-286, pp 345-348).
The teachings of Capistron are described supra.
Capistron teaches that the particles have a porosity of about 10-90% ([0008]) and Capistron teaches sintering hydroxyapatite particles and provides an example where the sample was heated for 2 hours ([0109]) but Capistron does not teach heating times from 3-24 hours as in claim 22. This deficiency is made up for in the teachings of Cox.
Cox teaches the effects of sintering temperature and time on hydroxyapatite (Title, Introduction). Cox tested sintering of hydroxyapatite at various times including 0, 1.5, 6 and 12 hours (page 345 last paragraph). Cox teaches that the sintering time influence the decomposition of hydroxyapatite between 0 and 12 hours (page 346 Results). Cox teaches that both the sintering temperature and time have a very significant effect on the phase stability, microstructure and microhardness of the material (page 347 Discussion). Cox provides data indicating that properties such as the density, microhardness and grain size are dependent on the sintering time (e.g. Figures 1-4) and indicates that increases in density and microhardness are primarily due to the decrease in porosity and indicates the influential nature of sintering time (page 347 last paragraph).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have adjusted sintering time for the hydroxyapatite particles of Capistron through a process of routine experimentation. In view of the teachings of Cox that the sintering time effects hydroxyapatite properties such as density, microhardness, grain size, and porosity, the sintering time is an art-recognized result effective variable such that determining that the time is between 3-24 hours would be a matter of optimization through routine experimentation. "[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). Sintering calcium hydroxyapatite particles is obvious from Capistron and a sintering time of 2 hours is even exemplified by Capistron. It is known from Cox that the time is a variable property for sintering hydroxyapatite and various times including 0, 1.5, 6 and 12 hours are demonstrated to lead to property differences such as density, microhardness, grain size, and porosity in the particles. Capistron teaches the particles with a porosity from about 10-90% and teaches an example time of 2 hours and it would be obvious to one of ordinary skill in the art to vary the time in order to reach the optimal particle parameters such as density, microhardness, grain size, and porosity.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 22 Jul 2026 have been fully considered but they are not persuasive. Applicant states that the Capistron discloses sintering for 2 hours and does not further discuss other sintering durations and one would not be motivated to select longer sintering times (page 8 of remarks). In view of the teachings of Cox, it is clear that the sintering time is a result effective variable and it would be obvious to determine the optimal holding time through routine experimentation.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/EDWIN COLEMAN MITCHELL/Examiner, Art Unit 1619
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