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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 28 May 2026 has been entered.
Priority
The application was filed 24 February 2021 and is the national stage entry of PCT/GB2019/052385 filed 27 August 2019. The Applicant claims priority to foreign application GB1813928.7 filed 29 August 2018. A translated copy of the foreign application has been provided. Therefore, the effective filing date of the application is 28 August 2018.
Examiner’s Note
The Applicant's amendments and arguments filed 04 May 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 04 May 2026, it is noted that claim 1 has been amended and claims 9 and 13 have been canceled. Support for the amendments can be found Table 1 of the instant specification. No new matter has been added.
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 and 2 are 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.
Claim 1 recites “wherein the solid suspension comprises strontium-substituted nanohydroxyapatite having at least 30% strontium.” It is not clear if the suspension comprises a concentration of 30% strontium or if the nanohydroxyapatite is 30% substituted with strontium. The claim is indefinite because the metes and bounds of the limitation cannot be determined. This limitation is herein interpreted as comprising a concentration of 30% strontium.
Claim 2 recites “further comprises calcium, strontium…” but instant claim 1 recites that the group II metal cation is strontium. The claim is indefinite because the metes and bounds of the limitation cannot be determined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 11 recites a particle size range that does not limit the range recited in instant claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 2, 7, 10-12, 14, 15, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamaki et al. (US 2012/0064343 A1) Gou et al. (CN 101695584 A), and Boyd et al. (WO 2011121087 A1), as evidenced by Tian et al. (Nano-to-Submicron Hydroxyapatite Coatings for Magnesium-based Bioresorbable Implants – Deposition, Characterization, Degradation, Mechanical Properties, and Cytocompatibility, Scientific Reports, 2018).
Regarding claim 1, Tamaki teaches a tooth surface repairing material (abs; entire teaching) comprising calcium phosphate, such as hydroxyapatite, which may be substituted with strontium ions (para. 42). The composition may further include zinc oxide (para. 73). The amount of calcium phosphate may be 0.1-70% (para. 47), which is interpreted as addressing the 30-60% range of solids. The amount of salt is dependent on the other components in the composition (para. 74). Tamaki’s composition for use as a tooth surface repairing material is interpreted as addressing “for use in bone regeneration.” Tamaki describes particles “dispersed” in solution (para. 69), which is interpreted as addressing a “solid suspension.” The calcium phosphate particles are also described as “nano meter sized” (para. 51), which is interpreted as addressing “nanohydroxyapatite.” In regards to the limitation of zinc oxide with a mean particle size below 3 microns, Tamaki describes salts mixed and generated on the surface of the particles (para. 70), where it is interpreted that the zinc oxide particle size would therefore also be within the range of the “nano meter sized” particles.
Regarding claim 2, Tamaki’s composition may comprise calcium phosphate that may be substituted with strontium ions (para. 42).
Regarding claim 7, calcium phosphate substituted with strontium ions is interpreted as forming strontium phosphate.
Regarding claim 10, since calcium phosphate may be partially or fully substituted with strontium, the ratio of calcium:strontium may be 0:100.
Regarding claim 11, Tamaki describes salts mixed and generated on the surface of the particles (para. 70), where it is interpreted that the zinc oxide particle size would therefore also be within the range of the “nano meter sized” particles.
Regarding claim 12, the composition may include water (para. 115).
Regarding claim 15, hydroxyapatite is a biodegradable and biocompatible ceramic (evidenced by Tian, pg. 2).
Regarding claim 19, Tamaki teaches a tooth surface repairing material (abs; entire teaching). Tamaki describes particles “dispersed” in solution (para. 69), which is interpreted as addressing a “solid suspension.” Furthermore, the solid suspension for use as a bone graft is interpreted as intended use and is given minimal patentable weight. See MPEP 2111.02(II).
Tamaki does not teach a zinc oxide amount of 2-5 wt%, a particle size of 3 microns for zinc oxide, or 30% of strontium in claim 1. Tamaki does not teach a mean particle size of 0.01-100 microns for zinc oxide in claim 11. Tamaki does not teach 2-3 wt% of zinc oxide in claim 14. Tamaki does not teach an exact combination of strontium-substituted nanohydroxyapatite and zinc oxide within a solid suspension in claim 1.
Gou et al. teach an injectable composite material for bone regeneration or repair (entire teaching; abs). The composite material may comprise hydroxyapatite doped with 0-3.5% ZnO or 0-5.5% SrO (claim 2).
Boyd teaches a suspension or slurry (pg. 15, lns. 1-13) biomaterial may comprise SrO to promote bone regeneration in bone tissue and the ideal molar percentage is between 10-40% (pg. 1, lns. 22-24). This amount is particularly ideal and effective in promoting bone regeneration in bone tissue (pg. 1, lns. 22-24).
In regards to selecting a combination of strontium-substituted hydroxyapatite and zinc oxide in claim 1, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. At 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Tamaki teaches a tooth surface repairing material (abs; entire teaching) comprising calcium phosphate, such as hydroxyapatite, which may be substituted with strontium ions (para. 42) and may further include zinc oxide (para. 73), whereas the claimed invention is directed towards a solid suspension comprising strontium-substituted nanohydroxyapatite and zinc oxide. Since Tamaki teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Regarding a zinc oxide amount of 2-5 wt% or 2-3 wt% in claims 1 and 14, a particle size of 3 microns or 0.01-100 microns for zinc oxide in claims 1 and 11, and 30% of strontium in claim 1, Boyd teaches a suspension or slurry (pg. 15, lns. 1-13) biomaterial may comprise SrO to promote bone regeneration in bone tissue and the ideal molar percentage is between 10-40% (pg. 1, lns. 22-24). This amount is particularly ideal and effective in promoting bone regeneration in bone tissue (pg. 1, lns. 22-24). Additionally, Gou teaches an injectable composite material for bone regeneration or repair (entire teaching; abs). The composite material may comprise hydroxyapatite doped with 0-3.5% ZnO or 0-5.5% SrO (claim 2). Furthermore, Tamaki describes salts mixed and generated on the surface of the particles (para. 70), where it is interpreted that the zinc oxide particle size would therefore also be within the range of the ‘nano meter sized” particles.
That being said and in lieu of objective evidence of unexpected results, the amounts and particle size can be viewed as a variable that achieves the recognized result of successfully making the solid suspension composition. The optimum or workable range of amounts and particle sizes can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of strontium, zinc oxide, and particle size of zinc oxide as nonobvious.
Response to Arguments
Applicant's arguments filed 04 May 2026 have been fully considered but they are not persuasive.
The Applicant argues that Gou teaches away from high solid suspensions (Remarks, pgs. 506). Specifically, the Applicant argues that Gou teaches roughly 31% of solids, but this is at the upper boundary of Gou’s teaching and there is no motivation to modify to a higher solids content (Remarks, pg. 6).
Applicant’s argument is not found persuasive. In response to the Applicant's argument that the references fail to show certain features of applicant’s invention, it is reminded that to properly teach away, the prior art reference must criticize, discredit, or otherwise discourage the solution sought. Merely teaching alternatives does not do this (see MPEP 2145 (X)(D)). Furthermore, Tamaki teaches a composition with 0.1-70% (para. 47) of calcium phosphate, which is interpreted as addressing the 30-60% range of solids.
The Applicant argues that Gou does not disclose zinc oxide particles with a mean particle size below 3 microns (Remarks, pg. 6).
Applicant’s argument is not found persuasive. The calcium phosphate particles are also described as “nano meter sized” (para. 51), which is interpreted as addressing “nanohydroxyapatite.” In regards to the limitation of zinc oxide with a mean particle size below 3 microns, Tamaki describes salts mixed and generated on the surface of the particles (para. 70), where it is interpreted that the zinc oxide particle size would therefore also be within the range of the “nano meter sized” particles.
The Applicant argues that Zou does not disclose nanohydroxyapatite (Remarks, pgs. 6-7).
Applicant’s argument is not found persuasive. Tamaki teaches a composition comprising hydroxyapatite (para. 42) wherein the particles are also described as “nano meter sized” (para. 51), which is interpreted as addressing “nanohydroxyapatite.”
The Applicant argues that Boyd does not remedy the deficiencies in Gou’s teaching (Remarks, pgs. 7-8).
Applicant’s argument is not found persuasive. Boyd a suspension or slurry (pg. 15, lns. 1-13) biomaterial may comprise SrO to promote bone regeneration in bone tissue and the ideal molar percentage is between 10-40% (pg. 1, lns. 22-24). This amount is particularly ideal and effective in promoting bone regeneration in bone tissue (pg. 1, lns. 22-24). Furthermore, in regards to Applicant’s argument of hindsight-based selections and modification, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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