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 .
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.
Claims 43,44,45,46,47,48,49,50,51,53,54 are rejected under 35 U.S.C. 103 as being unpatentable over Seeney et al 20050271732 in view of Tampieri et al 20130129634 and Shapiro et al 10576295.
With regard to claims 43,45,46,47,51,53, Seeney et al disclose a composition that could be used to treat a condition affecting a tooth or periodontium by delivery through dental tubules in a subject, comprising biocompatible magnetic agents and an effective amount of an agent. See paragraph 16. Note that the magnetic agents of Seeney et al may comprise a magnetic core coated with a shell comprising a biocompatible polymer. See paragraphs 23 and 26.
Seeney et al do not disclose that the agent may be a restorative/bonding material (note: the term “restorative/bonding material” is taken to mean a material that can be used for restorative or bonding purposes). However, it is noted that Seeney et al disclose that the agent does not need to be limited to those disclosed in the specific example. See paragraph 35 which discloses examples of other substances that may be used as the therapeutic agent. Note also that the magnetic agents may comprise particles.
Tampieri et al disclose that hydroxyapatite is a material that may be delivered magnetically, to a target area. It is noted that hydroxyapatite is a material that can be used for dental restorative purposes.
It would have been obvious to one skilled in the art to use hydroxyapatite as the material in the composition of Seeney et al, in view of the teaching of Tampieri et al that hydroxyapatite may be magnetically delivered to a target site, as well as the disclosure of Seeney et al that various agents may be delivered via the disclosed magnetic particles.
Seeney et al/Tampieri do not disclose the composition magnetic agents to have a size from 50nm to 1500nm, 300nm to 1200nm or 100nm to 300nm.
Shapiro et al disclose a similar composition in which the magnetic agents may have a particle size of from 20nm to 1 micrometer. This disclosed range includes values that are included in applicant’s claimed ranges in claims 43,46 and 51.
It would have been obvious to one skilled in the art to form the magnetic agents of Seeney et al/Tampieri et al with a particle size of from 50nm to 1500nm, 300nm to 1200nm or 100nm to 300nm as a matter of routine optimization, in view of the teaching of Shapiro et al that such particle sizes are suitable for magnetically controlled dispersion of therapeutic agents in the body. Furthermore, it is noted that "[W]here the general conditions of a claim are disclosed in the prior art, itis 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).
It is also noted that the magnetically responsive agents of Seeney et al/Tampieri et al/Shapiro et al could be pulled by magnetic forces under an applied magnetic field to be delivered into dentinal tubules to an unexposed pulp of the subject. The particle sizes contemplated in the disclosed range of Shapiro et would clearly allow such.
With regard to claim 44, note that the restorative agent may be bound to the magnetic agents covalently. See paragraph 19 of Seeney et al. Thus, since hydroxyapatite can be either ionically or covalently bonded (either by donating or sharing electrons), Seeney et al/Tampieri et al/Shapiro et al contemplates covalently bonding hydroxyapatite with the magnetic agents. With further regard to claim 44, the limitations in lines 3 and 4 that recite method of bonding are considered to be product by process limitations that carry no structural weight in an apparatus claim. Since the final product required by claim 44 (the composition of claim 43 further having the agent bound to the magnetic agents) is disclosed by Seeney et al, /Tampieri et al/Shapiro et al, then the Seeney et al/Tampieri et al/Shapiro et al reference meets this claim.
With regard to claim 48, note that the magnetic agents of Seeney et al may be superparamagnetic materials. See paragraph 29.
With regard to claims 49 and 50, note that the magnetic agents of Seeney et al may be nanoparticles comprising an iron core, which may be superparamagnetic (paragraph 29) iron oxide (magnetite, which is an iron oxide) nanoparticles. See paragraph 36.
With regard to claim 54, note that the restorative material of Seeney et al/Tampieri et al/Shapiro et al may be within the shell, with the release of the agent being sustained over a period of time. See paragraphs 26 and 27 of Seeney et al.
Allowable Subject Matter
Claim 120 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim 43 have been considered but are moot in view of the newly applied interpretation of the amended claim language. Applicant’s amendment necessitated this newly applied interpretation.
Conclusion
Applicant's amendment necessitated the modified 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS D LUCCHESI whose telephone number is (571)272-4977. The examiner can normally be reached M-F 800-430.
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/NICHOLAS D LUCCHESI/ Primary Examiner, Art Unit 3772