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
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 30 Jan 2026 has been entered.
Claims 16-35 remain pending in the application.
Claims 16, 21, and 26 are amended.
Claims 1-15 are canceled
Claims 27-30 and 33-35 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.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 16-26, 31 and 32 are under consideration to the extent of the elected species, i.e., that the pharmaceutically acceptable carrier is glycerol.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02 Apr 2026 is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections of claims pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 31 Oct 2025 are hereby withdrawn in light of applicants amendment of the claims.
Rejections Pursuant to 35 USC § 102
The rejection of claims pursuant to 35 U.S.C. 102(a)(1) set forth in the Non-Final Office Action mailed 31 Oct 2025 are hereby withdrawn in light of applicant’s amendment of the claims.
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 16-26, 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 the range of temperatures as in claims 16 and 21 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. Thus, the calcium hydroxyapatite particles sintered from about 900°C to about 1100°C, renders obvious the sintered calcium hydroxyapatite particles of claims 16 and 21.
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 a mean particle size of about 1 micron to about 30 microns, as determined by laser scatter ([0019]), rendering obvious claim 20. 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]), rendering obvious the times of claim 22.
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 lower sintering temperatures of claim 21, 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 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 30 Jan 2026 have been fully considered but they are not persuasive. Applicant states that Capistron does not teach or suggest to exclude/avoid temperatures above 995 °C and notes that the range of temperatures taught by Capistron and demonstrated in an example extends beyond 995 °C (page 8 of remarks). This is not persuasive as Capistron teaches temperatures from 800°C to 1200°C ([0016]), thereby including the claimed range. Capistron does not teach the temperature should not exceed 995 °C but Capistron also does not teach that the temperature should exceed 995 °C. Thus, each of the temperatures taught by Capistron are suitable for the invention and there is nothing to require that one would exceed 995 °C. Even though the example of Capistron noted by the applicant where heating was at 1000 °C is above the limit of 995 °C, this does not serve to overcome the case of obviousness presented. As noted, Capistron teaches temperatures other than 1000 °C as suitable and each one is obvious. One aspect of the example actually serves the argument for obviousness because Capistron heated at 1000 °C but didn’t extend to the upper temperatures taught. Thus, it is obvious to heat at a temperature within the range taught by Capistron and to maintain the temperature without exceeding to higher values.
Applicant points to examples 2and 3 and figures 5 and 10 of the instant specification disclose particles sintered at 970°C and not above 995°C have substantially increased collagen expression and fibrblastic cells compared to particles subjected to temperatures above 995°C and the unexpected result could not be derived from Capistron (page 8 of remarks). This is not persuasive as the data pointed to is insufficient to establish that the results are truly unexpected and the claims are not commensurate in scope with what was tested. Only a single temperature within the claimed range is tested (970°C) and is compared to two temperatures above the claimed limit (1070°C and 1170°C). It cannot be determined if there is something significant about the claimed range of 960-995°C or if this is just a general trend in response that one of ordinary skill in the art would determine through routine experimentation as a single data point does not sufficiently indicate unexpected results across the claimed range. For example, there is no indication what happens right above and below the claimed range. Capistron provided an example particle prepared at 1000 °C and there is nothing to indicate an unexpected result over this closest prior art. Further, there is a dependence on particle size as the difference between sintering temperatures was decreased as the particle size increased (shown in Figure 5). Thus, the data does not establish unexpected results across the claimed range and the data is not commensurate in scope with what is claimed.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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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/E.C.M./Examiner, Art Unit 1619 /ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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