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 1,3,5,11 are rejected under 35 U.S.C. 103 as being unpatentable over Flemmig et al 20040091429 in view of Losick et al 20130071439 (newly cited) in view of Hertz 6287180 and Meadows et al 3520656.
With regard to claim 1, Flemmig et al disclose a powder, and method of producing via a step of providing the powder, the powder capable of being used to clean an internal body part and/or an implant by means of a powder jet device, comprising providing a powder having a density between 0.2 and 1.6g/cm3 (1.16 g/cm3, see powder mixture I in Table 1).
However, Flemmig et al do not disclose that the powder comprises trehalose. It is noted, though, that Flemmig et al disclose that sugars may be included. See paragraphs 32 and 35.
Losick et al disclose an abrasive powder that may include a sugar, such as trehalose.
It would have been obvious to one skilled in the art to include trehalose as the sugar in the abrasive powder of Flemmig et al, in view of the teaching of Losick et al that dental abrasive powders may include trehalose.
Flemmig et al/Losick et al do not disclose that the powder is sterile as a result of a sterilizing process.
Hertz discloses a powder which may be used in a similar manner, and which is sterile as a result of a sterilization process. See col. 6, lines 19-21.
It would have been obvious to one skilled in the art to sterilize the powder of Flemmig et al/Losick et al via a sterilizing process as disclosed by Hertz, if one wished to reduce the risk of contamination while using the powder of Flemmig et al/Losick et al.
Flemmig et al/Losick et al/Hertz do not disclose the powder further comprising a hydrophobic coating comprising amorphous silica.
Meadows et al disclose an abrasive powder, in which the particles of the powder may have a hydrophobic coating of amorphous silica.
It would have been obvious to one skilled in the art to include a hydrophobic coating of amorphous silica on the particles of the abrasive powder of Flemmig et al/Losick et al/Hertz, in view of the teaching of Meadows et al that an abrasive powder can be coated with amorphous silica, such that the particles will be resistant to dissolving. See col. 55, lines 4-15.
Flemmig et al/Losick et al/Hertz/Meadows et al do not disclose that the powder has a water solubility above 1 g/L at a temperature of 20 degrees C. It is noted that Flemmig et al does disclose that the powder is mixed with water (water jet) when used during a cleaning operation. See paragraph 39 of Flemmig et al.
Therefore, it appears that one skilled in the art would have a reasonable expectation of success utilizing a water solubility of the powder of Flemmig et al/Losick et al/Hertz/Meadows et al to be in the range as claimed by applicant, as such would only involve adjusting the water solubility of the powder in order to achieve a specific level of abrasiveness of the powder, since Flemmig et al clearly discloses that the powder may be mixed with water upon application to the surface being treated.
Therefore, it would have been obvious to one skilled in the art to form the powder of Flemmig et al/Losick et al/Hertz/Meadows et al to have a water solubility above 1 g/L at a temperature of 20 degrees C as a matter of routine optimization, since it has been held that "[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 (CCPA1955).
With regard to claim 5, Flemmig et al/Losick et al/Hertz/Meadows et al do not disclose the amorphous silica being present in a volume ratio of 0.1 to 2.5%.
However, it appears that one skilled in the art would have had a reasonable expectation of success in selecting the amorphous silica coating material to be present in an amount that falls within the claimed range, as it only involves adjusting the amount of the coating to provide the stated desired property of resistance to dissolution. Therefore, it would have been obvious to one skilled in the art to provide the amorphous silica coating layer of Flemmig et al/Losick et al/Hertz/Meadows et al in a volume ratio of 0.1 to 2.5% as a matter of routine optimization.
With regard to claim 11, note that Hertz discloses that the powder may be sterilized by autoclaving, which inherently involves exposing the powder to a sterilizing vapor in the sterilizing process. See col. 6, lines 22-24.
With regard to claim 3, note that Flemmig et al disclose that the powder may have an average grainsize between 5 and 100 um (10.7 um, see powder mixture I in Table 1 of Flemmig et al).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Flemmig et al 20040091429 in view of Losick et al 20130071439, Hertz 6287180 and Meadows et al 3520656, and further in view of Anderson et al 4937046.
With regard to claim 7, Flemmig et al//Losick et al/Hertz/Meadows et al does not disclose exposing the powder to ethylene oxide gas in the disclosed sterilization method.
Anderson et al discloses a sterilization method that utilizes ethylene oxide gas. See col. 2, lines 59-63.
It would have been obvious to one skilled in the art to use ethylene oxide gas in the sterilization method of Flemmig et al/Losick et al/Hertz/Meadows et al, in view of the teaching of Anderson et al that ethylene oxide gas is known to be effective in sterilization procedures.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Flemmig et al 20040091429 in view of Losick et al 20130071439, Hertz 6287180 and Meadows et al 3520656, and further in view of Piacenza 6207201.
With regard to claim 8, although Flemmig et al/Losick et al/Hertz/Meadows et al discloses (see Hertz, col. 6, line 24) the use of chemical forms of sterilization, Hertz does not explicitly disclose the use of sodium hypochlorite.
Piacenza discloses methods of sterilization of materials, using sodium hypochlorite. See col. 3, lines 3-32.
It would have been obvious to one skilled in the art to use sodium hypochlorite in the sterilization method of Flemmig et al/Losick et al/Hertz/Meadows et al, in view of the teaching of Piacenza that sodium hypochlorite is effective in chemical sterilization methods.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Flemmig et al 20040091429 in view of Losick et al 20130071439, Hertz 6287180 and Meadows et al 3520656, and further in view of Duthie, Jr. 5547635.
With regard to claim 9, although Flemmig et al/Losick et al/Hertz/Meadows et al discloses sterilization via autoclaving (see col. 6, line 24 of Hertz), Hertz does not explicitly disclose sterilizing by heating the powder to a temperature between 110 degrees C and 210 degrees C.
Duthie, Jr. disclose methods of sterilizing, in which materials are heated to 140 degrees C, which falls within applicants claimed range. See col. 3, lines 25-51.
It would have been obvious to one skilled in the art to heat sterilize the powder of Flemmig et al/Losick et al/Hertz/Meadows et al to a temperature of 140 degrees C, in view of the teaching of Duthie, Jr. that heating materials to a temperature of 140 degrees C allows for sterilization of such materials.
With regard to claim 10, although Flemmig et al/Losick et al/Hertz/Meadows et al discloses that irradiation (col. 6, lines 22- 24 of Hertz) may be used to sterilize the disclosed powder, Hertz does not explicitly disclose the use of UV radiation.
Duthie, Jr. discloses a method of sterilization, which utilizes UV radiation. See col. 3, lines 25-
51.
It would have been obvious to one skilled in the art to use UV radiation as the radiation to sterilize the powder disclosed by Flemmig et al/Losick et al/Hertz/Meadows et al, in view of the teaching of Duthie, Jr. that UV radiation is effective in sterilizing materials.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over over Flemmig et al 200400961429 in view of Losick et al 20130071439, in view of Hertz 6287180 and Meadows et al 3520656, and further in view of Anderson et al 4937046 and Duthie, Jr. 5547635.
With regard to claim 13, Flemmig et al//Losick et al/Hertz/Meadows et al does not disclose exposing the powder to ethylene oxide gas in the disclosed sterilization method.
Anderson et al discloses a sterilization method that utilizes ethylene oxide gas. See col. 2, lines 59-63.
It would have been obvious to one skilled in the art to use ethylene oxide gas in the sterilization method of Flemmig et al/Losick et al/Hertz/Meadows et al, in view of the teaching of Anderson et al that ethylene oxide gas is known to be effective in sterilization procedures.
Although Flemmig et al/Losick et al/Hertz/Meadows et al/Anderson et al discloses that irradiation (col. 6, lines 22- 24 of Hertz) may be used to sterilize the disclosed powder, Hertz does not explicitly disclose the use of UV radiation.
Duthie, Jr. discloses a method of sterilization, which utilizes UV radiation. See col. 3, lines 25-
51.
It would have been obvious to one skilled in the art to use UV radiation as the radiation to sterilize the powder disclosed by Flemmig et al/Losick et al/Hertz/Meadows et al/Anderson et al, in view of the teaching of Duthie, Jr. that UV radiation is effective in sterilizing materials.
Response to Arguments
Applicant's arguments filed 10/28/25 have been fully considered but they are not persuasive.
Applicant argues (page 6 of response) that the combination of references and routine optimization analysis does not provide one skilled in the art with a reasonable expectation of success to modify the powder to be in the range claimed by applicant because it has not been established as to how one skilled in the art should adjust the water solubility of the powder.
This is not found persuasive. Under the routine optimization standard, there is no requirement for a showing of “how” one skilled in the art would arrive at the claimed range. The only requirement is that the articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See MPEP 2144.05 As explained above, it is the examiner’s position that one skilled in the art of utilizing abrasive powders that are assisted by a water jet, would know that the abrasive powder must have a particular solubility, in order to prevent that powder from dissolving during use with a water jet. One skilled in the art would recognize that such a powder should have a solubility that allows for usage with a water jet, while maintaining effectiveness as an abrasive in a dental procedure. It is further noted that the solubility claimed has not been shown to be critical, as applicant’s specification discloses a wide range of solubilities. See p. 4, lines 25-30, as well as the table on page 5 of applicant’s specification.
Applicant also argues (page 6 of response) that a particular parament must first be recognized as a result-effective variable before the determination of the optimum or workable ranges of the variable might be characterized as routine experimentation, and cites In re Antoine for support. This is not found persuasive, as the decision in In Re Antoine was applied to a rationale that was based on the “obvious to try” standard, which was not applied in the above rejection. While applicant also cites In Re Boesch, it is not clear as to how this citation supports applicant’s position, since In Re Boesch is most relevant to the issue of criticality, which has not been demonstrated by applicant.
Applicant also argues that the rejection of claims 7,10 is based only on hindsight. This is not found persuasive, as the cited references to Duthie, Jr. et al and Anderson et al clearly disclose the limitations recited in these claims. It is the examiner’s position that one skilled in the art, after reading the disclosures of Duthie, Jr. et al and Anderson et al would recognize that these claim limitations are obvious.
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 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