DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 11/19/2025 wherein claims 1 and 10-12 have been amended and claims 13-17 have been added.
Claims 1-6 and 10-17 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendments filed 11/19/2025 render moot the rejection of claim 1 made by the Examiner under 35 USC 112(b). This rejection has been withdrawn.
Applicant’s arguments filed 11/19/2025 regarding the rejection of claims 1-6 and 10-12 made by the Examiner under 35 USC 103 over De Silva Santos et al. (US 2011/0159057) in view of Healy et al. (US 6692532) have been fully considered but not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 8/19/2025.
In regards to the 103 rejection, Applicant asserts the following:
A) the experimental data obtained following clinical trials in sheep and dogs using a composition reflective of the claimed composition exhibited unexpected and advantageous benefits.
In response to A, the data provided in the response is certainly interesting and could be supportive of nonobviousness. However, the data would need to be provided as a declaration together with comparative data showing that the specifically claimed granulometry performs other granulometry. The claimed granulometry is still considered obvious because Gilchrist teaches that their bone glass mixture comprises particles having a size of between 100 um to 10 mm with a particle size distribution wherein about 28% of the particles have a size of between 500 um to 1 mm and about 56% of the particles have a particle size of between 2-6 mm. For reference the instant claims require:
PNG
media_image1.png
92
590
media_image1.png
Greyscale
It is observed that Gilchrist’s lower granulometry bound (500 um-1 mm) overlaps the claimed bottom two granulometry tiers whereas the upper bound (2-6 mm) overlaps with the top granulometry tier. Regarding the unexpected results, the Examiner reviewed the data provided in the specification but was unable to identify any comparative data which would support Applicant’s finding of unexpectedness. As of now, the Examiner maintains that absent a sufficient showing that one of ordinary skill in the art would be capable of parsing out particle size preferences capable of resulting in a desired bone matrix within the framework of that desired/described by De Silva and Gilchrist capable of providing therapeutic benefit. Applicant’s arguments are not considered persuasive.
Maintained Rejections, of Record (claims 1-6) and New Rejections, Necessitated by Amendment (claims 10-17)
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 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.
Claims 1-6 and 10-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Silva Santos et al. (US 2011/0159057; of record) in view of Healy et al. (US 6692532; of record).
De Silva Santos (Santos herein) describes a hydroxyapatite bioglass material that is useful in the field of medicine as a bone graft/regeneration material (see abstract) (see instant claims 5, 6 and 10-12).
The bioglass is added to hydroxyapatite in a weight percentage of 10% or less relative to the hydroxyapatite (see [0024]) (see instant claims 1 and 14).
The bioglass is a P2O5:CaO glass and contains a molar ratio for P2O5:CaO of 20:80 to 80:30 (see [0021]) (see instant claims 1 and 3).
The bioglass is to be porous, having a global porosity of at least 20% and an intra- and interporosity of at least 20% by volume (see [0019]) (see instant claim 1) wherein the pores include micro- and macropores, the macropores having a diameter (i.e. size) of between greater than 50 microns (see instant claims 1 and 15) and the micropores having a size up to 5 microns (see [0019]) (see instant claims 1 and 16). See MPEP 2144.05(I) regarding the obviousness of overlapping ranges.
Santos teaches that the bioglass may comprise 0-20 mol% of CaF2, Na2O and MgO (see [0021]) (se instant claims 2 and 3).
The hydroxyapatite bioglass material may be a pellet (see title) or a powder (see [0026]) (see instant claim 4).
Santos fails to teach the hydroxyapatite material as having a size ranging from 150 μm to 6 mm, wherein the granules have a distribution such that 10 to 20% of the particles are in a range of 150 to 500 μm, 30 to 50% of the particles are in a range of 500 μm to 2 mm, and 40 to 60% of the granulometry varies in a range of 2 to 5.6 mm.
Gilchrist describes a bone glass formulation, the glass being similar in nature to that claimed, e.g. comprising P2O5, CaO, (see column 4, lines 37-45). The glass is to have a particle size of between 100 μm to 10 mm (see column 2, lines 42-44) (see instant claim 17) and a particle size distribution (i.e. granulometry) wherein about 28% of the particles have a size of between 500 μm to 1mm and about 56% of the particles have a particle size of between 2-6 mm (see column 2, lines 49-57) (see instant claim 1). It is taught that by providing such a particle size distribution, the composition exhibits excellent mechanical stability and is able to cement into healthy bone tissue in a similar manner to a bridge pile sunk into a gavel aggregate. See MPEP 2144.05(II)(A) which states that where the general conditions of a claim are described by the prior art, identifying optimum or workable ranges by routine experimentation is not considered inventive. Thus, modulating the particle size distribution of the bioglass of Santos, like that described by Gilchrist, would have been an obvious parameter to manipulate so as to identify a distribution that would yield the best osteogenic outcome. If such manipulation resulted in a distribution overlapping with that claimed, such a result would have been a product of ordinary skill and common sense, not one of innovation.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
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.
Claim 1 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor.
Claim 1 recites, “… the microporous size ranges from 50um to 600m, from 2006-600um, and the microporous size ranges from 550 nm to 2 um, of 550nm to 1.5 um…”. There appears to be multiple limitations in regards to both of the the microporous and microporous size ranges and it is not clear what is limiting/required. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP 2173.05(c). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Hybrid/Use Claims
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.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 10-12 provide for the use of the hydroxyapatite-bioglass material, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass.
A claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. Furthermore, a claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. In all, claims 10-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter and under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. See MPEP 2173.05(q).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/KYLE A PURDY/Primary Examiner, Art Unit 1611
Prosecution Insights