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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-5, 7 and 9-19) in the reply filed on 05/12/2025 is acknowledged.
Claims 20, 39 and 40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/12/205.
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.
Claims 1-3, 5, 7, 9-13, 15-19 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Moseley et al. WO 2015/089373 A1 (Moseley ‘373), in view of Moseley et al. 9,180,224 B2 (Moseley ‘224).
Moseley ‘373 teaches a bone graft substitute cement upon mixing with an aqueous solution, comprising i) a calcium sulfate hemihydrate powder, wherein the calcium sulfate hemihydrate is present at a concentration of at least about 50 weight percent based on the total weight of the particulate composition; ii) a monocalcium phosphate monohydrate powder; iii) a non-porous ß-tricalcium phosphate powder; and iv) a porous ß-tricalcium phosphate powder. Bone graft substitute cements made therefrom, and a bone graft substitute kit comprising the particulate composition. See Abstract, pages 2-4 and 7-12. The porous β-tricalcium phosphate powder comprises less than 50% by weight of particles having a particle size up to about 63 microns and greater than 50% by weight of particles having a particle size greater than about 63 microns. In certain embodiments, the porous β- tricalcium phosphate powder comprises about 25%> by weight of particles having a particle size up to about 63 microns and about 75% by weight of particles having a particle size greater than about 63 microns. The non-porous β-tricalcium phosphate powder can have, for example, a median particle size of less than about 20 microns. In some embodiments, the non-porous β-tricalcium phosphate powder has a bimodal particle size distribution comprising about 30 to about 70 volume percent of particles having a mode of about 2.0 to about 6.0 microns and about 30 to about 70 volume percent of particles having a mode of about 40 to about 70 microns based on the total volume of the β- tricalcium phosphate powder. In some embodiments, the β-tricalcium phosphate powder has a bimodal particle size distribution comprising about 50 to about 65 volume percent of particles having a mode of about 4.0 to about 5.5 microns and about 35 to about 50 volume percent of particles having a mode of about 60 to about 70 microns based on the total volume of the β- tricalcium phosphate powder. See pages 3-4. The particulate composition can, in some embodiments, further comprise an accelerant adapted for accelerating the conversion of calcium sulfate hemihydrate to calcium sulfate dihydrate. For example, the accelerant can be selected from the group consisting of calcium sulfate dihydrate particles, potassium sulfate particles, and sodium sulfate particles, wherein the accelerant is optionally coated with sucrose. In some embodiments, the accelerant may be present at a concentration of up to about 1 weight percent based on the total weight of the particulate composition. See page 4. Bone graft cement has a Vicat set time of about 10 to 60 minutes is found in pages 25-26. Injection and syringe having the claimed gauge needle is found in pages 27-29.
Moseley ‘373 does not expressly teach the claimed injection force performed using a 14 mL syringe and an 11 gauge needle.
Moseley ‘224 teaches a particulate composition for bone grafting with a desired consistency and hardening or setting time. Typically, the aqueous solution is provided in an amount necessary to achieve a liquid to powder mass ratio (L/P) of at least about 0.2, more preferably at least about 0.21, and most preferably at least about 0.23. A preferred L/P ratio range is about 0.2 to about 0.3, more preferably about 0.2 to about 0.25. The bone graft substitute cement according to the invention can be formed by mixing the particulate composition with the aqueous solution using manual or mechanical mixing techniques and apparatus known in the art. It is preferred to mix the components of the cement at atmospheric pressure or below (e.g., under vacuum) and at a temperature that will not result in freezing of the aqueous component of the mixture or significant evaporation. Following mixing, the homogenous composition typically has a paste-like consistency, although the viscosity and flowability of the mixture can vary depending on the additives therein. The bone graft substitute cement material can be transferred to a delivery device, such as a syringe, and injected into a target site, for example, to fill in cracks or voids of a bone defect. In some embodiments, the material can be injected through an 11 to 16-gauge needle up to, for example, 10 cm long. The bone graft substitute cements of the invention will generally set, as defined by the Vicat needle drop test set forth below, in about 3 to about 25 minutes, more preferably about 10 to about 20 minutes. The bone graft substitute cement material of the invention will typically reach a hardness comparable to or greater than bone within about 30 to about 60 minutes. Setting of the material can occur in a variety of environments, including air, water, in vivo, and under any number of in vitro conditions. See columns 14-15. The nine sets of units (three units of unsterilized solution and unsterilized powder, three units of one time bulk sterilized solution and unit sterilized powder, and three units of two times sterilized solution (once in bulk followed by once as a unit) and one time unit sterilized powder) were mixed to form a homogeneous paste under vacuum. Set times of approx. ¼ in. thick aliquot of paste in a 25 mL plastic cup were determined through the use of a 300 g Vicat needle. Injection force from a 3 cc syringe attached to a 6 cm 11 gauge non-tapered, ported jamshidi type needle was determined at 3 and 5 minutes after the powder and solutions had come into contact with one another. Injection forces are reported as forces seen at 15 mm of plunger displacement being displaced at 4.4 mm/sec. Injection testing was performed using a materials test frame in displacement control, and data acquisition was taken at 50 Hz of force and displacement. The claimed injection force can be found in Example 3, namely, the injection force of between about 25 N and about 40 N.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the composition of Moseley ‘373 in view of the teaching of Moseley ‘224 to obtain a bone graft formulation having an injection force between about 25 N and about 40 N with the expectation to provide a bone graft composition with a desirable resorption rate, high mechanical strength, ease of handling and osteoconductivity.
Response to Arguments
Applicant's arguments filed 07/14/2026 have been fully considered but they are not persuasive.
Applicant argues that both of the cited Moseley references relate to a Vicat set time between 3 and 25 minutes and fails to teach the claimed Vicat set time of about 30 minutes to about 55 minutes. Thus, because a setting time, which relates to the time to undergo a transformation from a flowable solution to a rigid solid, and a hardening time, which relates to the time needed to build up and develop the underlying strength of the rigid solid material formed by setting, are separate and distinct concepts, a person of ordinary skill in the art would have found no teaching or suggestion in Moseley '373 and Moseley '224 to have found it obvious to arrive at the instantly- claimed subject matter having the claimed Vicat set time. Therefore, the instant claim 1 is nonobvious and allowable over Moseley '373 and Moseley '224. By virtue of their dependency from claim 1, which is allowable, claims 2-5, 7, 9-19 are also allowable over Moseley '373 and Moseley '224 and for the additional features recited therein.
Accordingly, Applicant respectfully requests that the rejection based on Moseley '373 and Moseley '224 be withdrawn.
However, Applicant’s arguments are not persuasive for the following reasons:
It is noted that Claim 1 recited the time for Vicat set time of “about 30 minutes”. Here, Applicant’s attention is called to the term “about”. While Moseley does not teach the Vicat setting time at about 30 minutes, Moseley teaches a Vicat setting time at about 25 minutes. Applicant’s attention is called to the disclosure in paragraph 0024 of the present specification which defined the term “about” to include value or parameter that also include aspects that are directed to that value or parameter. Given the teaching in Moseley for the Vicat time of “about” 25 and the Vicat time requires in claim 1 of “about” 30, one of ordinary skill in the art would have been motivated to, by routine experimentation select a Vicat time that falls within about 30 minutes;
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."); and
Furthermore, it is noted that the Vicat time in a wet environment is lower than Vicat setting time in a dry environment. See paragraph 0009. Here, the Moseley references are silent with respect to the wet or dry environment for the disclosed setting time. Therefore, the burden is shifted to the Applicant to show that the bone graft composition taught in Moseley does not exhibit the Vicat setting time that falls within the claimed range, in a dry environment.
Thus, for at least the above reasons, the rejection over Moseley is maintained.
Claim 4 is allowed.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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