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 .
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 12 November 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 12 November 2025, it is noted that claims 1, 2, 7, 9, and 10 have been amended and claim 8 has been canceled. Support for the amendments can be found on pg. 3, lns. 29-36 of the instant specification. No new matter has been added.
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, 9-15, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gou et al. (CN 101695584 A) and Boyd et al. (WO 2011121087 A1).
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), addressing claims 1, 2, 7, 12, and 14. Since the composition may comprise strontium, the ratio of calcium:strontium may be 0:100, addressing claim 10. The composition may have a diameter of 50-800 nm (0.05 to 0.8 microns) (claim 5), which addresses the particle size limitation of claim 11 and the nano-hydroxyapatite limitation of claim 9 based on the Applicant’s description (specification, pg. 3). The material may comprise 30-45% of deionized water, as well as 0.10-0.50% of sodium alginate, 0.01-0.20% of chitosan, 5-30% of the microspheres, 0.05-0.50% of nanoparticles, and 25-55% of cell culture medium (abs). The amount of solid material in the composition may be roughly 5-31% based on the amount of sodium alginate, chitosan, microspheres, and nanoparticles, addressing claim 13. Gou teaches that the composition is biodegradable (abs, para. 40), which is interpreted similarly as bioresorbable, which addresses claim 15, and the composite material used for bone regeneration or repair is interpreted as capable of being used as a bone graft in claim 19.
Gou et al. do not specifically teach a composition comprising a combination of one group II metal cation and a source of zinc cations in claim 1. Gou et al. do not specifically teach at least 30% of strontium in claim 1.
In regards to selecting a combination of ZnO, SrO, and water, “[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
combination 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.”
Gou teaches an injectable composite material for bone regeneration or repair that may comprise hydroxyapatite doped with ZnO or SrO, whereas the claimed invention is directed towards a solid suspension for use in bone regeneration and comprises a group II metal cation and a source of zinc cations. Since Gou 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.
In regards to the amount of strontium in claim 1, Boyd teaches that their 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). That being said and in lieu of objective evidence of unexpected results, the amounts can be viewed as a variable that achieves the recognized result of successfully making the ZnO suspension composition. The optimum or workable range of amounts 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 as nonobvious.
Response to Arguments
Applicant's arguments filed 12 November 2025 have been fully considered but they are not persuasive.
The Applicant argues that there is no reasonable expectation of success to combine the elements taught in Gou (Remarks, pg. 5).
Applicant’s argument is not found persuasive. The Applicant is reminded that the teachings of KSR are actually an endorsement and expansion of the flexible and expansive approach to obviousness, which clearly invites continued reliance on such broad and flexible analyses concerning the utility of selecting alternative embodiments of components providing art-recognized utility, with no substantial change in the overall utility of a composition so formulated. See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385, 1395-96 (U.S.2007) (“the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”; “When 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”; “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions” exemplified by the holdings of cases such as Merck v. Biocraft.
Furthermore, Gou teaches an injectable composite material for bone regeneration or repair that may comprise hydroxyapatite doped with ZnO or SrO, whereas the claimed invention is directed towards a solid suspension for use in bone regeneration and comprises a group II metal cation and a source of zinc cations. Since Gou 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.
The Applicant argues that Gou does not teach a solid suspension (Remarks, pg. 5).
Applicant’s argument is not found persuasive. A solid suspension is defined as a homogeneous mixture of a solid in a liquid (instant specification, pg. 2). Gou describes an embodiment where the solid powder is dispersed in a liquid medium to prepare a suspension (paras. 51-54). Therefore, the formulation provided in Gou is interpreted as a solid suspension.
The Applicant argues that Gou teaches the importance of trace amounts of elements for bone defect repair (Remarks, pgs. 5-6).
Applicant’s argument is not found persuasive. Applicant’s recitation of Gou’s teaching is interpreted to mean that only trace amounts of the elements are needed for the composition, and not that Gou is attempting to teach away or discourage the use of larger amounts of the elements.
The Applicant argues that Boyd teaches a solid load-bearing structure, which is allegedly not a solid suspension (Remarks, pg. 6).
Applicant’s argument is not found persuasive. Boyd teaches a composition for both load-bearing and non-load-bearing applications (pg. 2, lns. 14-17), where non-load-bearing is interpreted as injectable administration (evidenced by Ventura, abs). Furthermore, Boyd describes their composition as a suspension or slurry (pg. 15, lns. 1-13), where a slurry is interpreted as solid particles suspended in a liquid mixture (evidenced by proquipinc.com, pg. 1).
The Applicant argues that a POSITA would not have been motivated to combine Gou’s and Boyd’s teachings (Remarks, pgs. 6-7).
Applicant’s argument is not found persuasive. As previously mentioned, Boyd teaches a composition for both load-bearing and non-load-bearing applications (pg. 2, lns. 14-17), where non-load-bearing is interpreted as injectable administration. Boyd also describes their composition as a suspension or slurry (pg. 15, lns. 1-13), where a slurry is interpreted as solid particles suspended in a liquid mixture. Since Boyd teaches that their 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), a person of ordinary skill in the art would have a reasonable motivation to modify Gou’s teaching to arrive at the claimed invention.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613