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 .
Amendments
Applicants’ amendments to the claims filed 1/28/2026 have been entered. Any objection\rejections from the previous office action filed 10/30/2025 not addressed below has been withdrawn.
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.
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.
Claim(s) 1-2,5-7,9-14,16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over LIDGREN (WO 2016/150,876), alone or in view of Valimaki et al. “Effect of zoledronic acid on incorporation of a bioceramic bone graft substitute”, Bone 38 (2006) 432–443, in view of Panchbhavi “The Use of Calcium Sulfate and Calcium Phosphate Composite Graft to Augment Screw Purchase in Osteoporotic Ankles”, Foot & Ankle International/Vol. 29, No. 6/June 2008, for the reasons set forth in the previous action filed 10/30/2025.
Claim(s) 1-2,5-14,16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over LIDGREN (WO 2016/150,876), in view of Valimaki et al., cited above, in view of Panchbhavi, cited above, in view of Alsberg et al. (2017/0183629 A1), for the reasons set forth in the previous action filed 10/30/2025.
Response to Arguments
Applicant's arguments filed 1/28/2026 have been fully considered but they are not persuasive.
Applicants assert Lidgren teaches that bisphosphonates at high levels are toxic, therefore applicants surmise the reference teaches away from its use.
The passage applicants refer to is only stating that high doses of bisphosphonate should be avoided which is why the reference teaches use of lower doses of zoledronic acid (bisphosphonate). The reference clearly teaches use of bisphosphonates and the passage in no way teaches away from their use, only that high doses should be avoided.
Applicants assert Valimaki focuses on bioactive glasses and not calcium phosphates or sulfates. Thus, applicants surmise that adjunct therapy with bioactive glass would have no bearing on hydroxyapatite-based ceramics.
The Valimaki reference was used only for its teaching that that systemic administration (intravenous) of zoledronic acid after bone graft implantation promoted the biological action of bioceramics in bone. Since the references are at least related in their teaching of bone graft implantation for bone repair one of ordinary skill would have a high expectation of success in improving the biological action in bone substitutes by systemic administration of bisphosphonates. It is further noted by the examiner that the primary reference Lidgren further teaches that it was known before the time of the claimed invention that bisphosphonates administered systemically, including intravenously and orally, targeted and bound to areas of active bone remodeling and the bisphosphonates prevent bone resorption. See page 2 lines 20-33. Therefore, one of ordinary skill in the art would have good reason to continue delivery of bisphosphonates after the bone substitute is implanted until the bone is fully healed.
Applicants assert Panchbhavi injects calcium sulfate/calcium phosphate prior to screw insertion while the claims require it be administered after inserting the device.
As noted in the prior action since Lidgren and Panchbhavi each teach calcium phosphate and calcium sulfate bone repair compositions and Lidgren suggest use of its composition with bone repair devices one of ordinary skill would have a very high expectation of success in using the composition of Lidgren to augment a bone screw to heal bone by adding the composition and screw to a predrilled cavity as claimed. The sequence of inserting the device then adding the composition would readily be obvious to one of ordinary skill. See MPEP 2144.04 [R-6] IV. C. Changes in Sequence of Adding Ingredients Ex parte Rubin , 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
With regard to Alsberg, applicants assert the reference is silent with respect to a mixture of sizes. Applicants pick on Alsberg for not exemplifying hydroxyapatite alone or varying its size. Applicants assert Lidgren and Alsberg are too different to combine as Lidgren deals with bioceramics bone substitute and Alsoberg is drawn to shaping tissue constructs.
It is noted by the examiner that only claim 8 requires two different sizes of micro and nano-sized first material. Alsberg was used primarily for its teaching that inorganic particles of hydroxyapatite nanoparticles and/or microparticles size can vary to adjust the mechanical properties and release rate. See [0069] and [0081]-[0082]. The entire body of Alsberg was not incorporated into the primary reference, only the knowledge that inorganic nanoparticle/microparticle size could be used to adjust mechanical properties. From the suggestion that particle size influences’ release rate one of ordinary skill in the art would have good reason to mix hydroxyapatite nanoparticles to hydroxyapatite microparticles, as taught in Alsberg. Reason to make such a modification would be to have additional control over the mechanical and release properties of the bone implant. With regard to Alsberg providing no examples of hydroxyapatite micro and nano particle mixture, the examples within Alsberg were given solely for the purpose of illustration and were not to be construed as being limiting to their invention since many variations are possible without departing from the spirit and scope of the invention.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618