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
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 1-2, 5-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ammon et al. (US 2012/0282571, hereafter “Ammon”).
Regarding claim 1, Ammon discloses a method of manufacturing a working area for a root canal instrument 10 (endodontic file- ¶ [0006, 0010]; fig. 2) comprising the steps: providing a strand made of a nickel-titanium alloy and cutting the strand to a blank size of the working area 12 (¶ [0038, 0042, 0054]), forming a tip 18 in the working area of the instrument 10 (figs. 1A-1C); heat-treating the working area at a temperature of about 350 to 600 °C for about 3-30 minutes ([0059-0061], claim 3) - including preferable temperature of about 400°C [0059] and preferable time of about 5-20 min [0060], which overlaps with recited heat-treating conditions of 400 to 430 °C for 25 to 40 minutes; quenching of the heat-treated working area to room temperature [¶ 0190, 0199] and producing a final geometry of the working area, wherein the nickel-titanium alloy contains exclusively nickel and titanium as metal components (NiTi alloy- [0021]). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990), MPEP 2144.05. Examiner also notes that any shape meets broad term “final geometry” since claim does not require a specific geometrical shape.
As to claim 2, Ammon discloses that the heat treatment is carried out by resistance heating [0198-0199].
As to claim 5, Ammon shows rounded working area in the tool 10 (fig. 1A). It would have been obvious to an artisan to round the working area after forming the tip in order to provide proper finishing for the instrument needed for root canal treatment (fig. 2).
As to claim 6, one of ordinary skill in the art would have found it obvious to perform quenching using water in the method of Ammon since water is conventionally known coolant.
As to claims 7-8, Ammon discloses producing the final geometry of the working area 12 comprises grinding teeth or depth marks (flutes), wherein the depth mark is ground into an area discolored by the heat-treating and quenching (fig. 1A; [0062-0064]).
As to claims 9-10, Ammon discloses connecting the working area (12) to a shaft to produce the tool 10 (figs. 1A-1A, [0042, 0136]). It would have been obvious to one of ordinary skill in the art to make the connection of the working area to the shaft by any of pressing, welding or molding as they are well-recognized attachment techniques within common knowledge in the art.
As to claim 12, Ammon discloses a root canal instrument 10 (fig. 1).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Ammon as applied to claim 1 above and in view of Johnson (US 2014/0242543).
As to claims 3-4, Ammon does not specifically mention the nickel-titanium alloy comprises carbon and/or oxygen as further components. Analogous to Ammon, Johnson also discloses endodontic instrument or file made of Nitinol (Ni-Ti alloy) material [0012, 0016]. Johnson teaches the nickel-titanium alloy consists of 54 to 57 mass% nickel & the balance titanium with trace elements of a maximum of 0.05% carbon and a maximum of 0.05% oxygen [0024]; the Nitinol material significantly increases the instrument’s cyclic fatigue resistance [0017]. Therefore, it would have been obvious to one of ordinary skill in the art to utilize Nitinol material similar to Johnson for the root canal instrument in Ammon because it would result in significant improvement to cyclic fatigue resistance.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ammon as applied to claim 9 above and in view of Hagemann et al. (EP 1279378 A2, see attached document).
As to claim 11, Ammon is silent with respect to color marking or mounting a stopper. However, such feature is known in the art. Hagemann (also drawn to endodontic instruments) teaches a root canal instrument provided with raised marking rings, which allows the dentist to monitor and control the depth of penetration [0021]. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide color markings to the root canal tool of Ammon because it would allow the dentist to easily monitor and control the depth of penetration during treatment procedure.
Response to Arguments
Applicant's arguments filed 1/28/26 have been fully considered but they are not persuasive for following reasons.
With respect to claim 1, Applicant argues (pg. 2 of Remarks):
Ammon's second heat treatment step at 400-500°C for 40-70 minutes (which the Examiner relies upon for overlap) requires a preceding first heat treatment step at 300- 650°C, making Ammon's process fundamentally different from the presently claimed single heat treatment at 400-430°C for 25-40 minutes.
In response, examiner contends that claim 1 is not limited to only “single” heat treatment step as argued above. The claim reciting “comprising” is open to other steps and also does not require specific order (e.g. forming a tip after heat-treating step). Ammon’s post heat treatment of instrument (endodontic file) working area after manufacturing the instrument/file [0058-0059] overlaps with claimed heat treatment. In response to argument that Ammon fails to show certain features of the invention, examiner submits that the features upon which Applicant relies (i.e., single heat treatment step) are not recited in the rejected claim(s). The argument is not commensurate with the scope of the claim. In other words, two or more stages of heat treatment are not excluded by the instant claim. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant further argues (pg. 3 of Remarks):
Regarding obviousness, it is noted that the claimed subject matter differs from the disclosure of Ammon with regards to at least the definition of a heat treatment step at a temperature of explicitly 400° to 430°C for a period of time of 25 to 40 minutes.
The claimed heat treatment parameters of 400 to 430°C for 25 to 40 minutes
represent a specific and narrow range that is key to achieving the desired properties in the present invention.
Applicant submits that Ammon's broad disclosure of heat treatment at
temperatures ranging from 350 to 600°C for 3-30 minutes does not teach or suggest the specific combination of temperature and time recited in claim 1. Furthermore, the specific narrow temperature range of 400 to 430°C, when combined with the specific duration of 25 to 40 minutes, represents a precise processing window that one of ordinary skill in the art would not have been motivated to select from Ammon's broad disclosure without the benefit of hindsight derived from the Applicant's own disclosure.
In response, examiner respectfully disagrees. Ammon teaches heat-treating the working area at a temperature of about 350 to 600 °C for about 3-30 minutes ([0059-0061], claim 3) - including preferable temperature of about 400°C [0059] and preferable time of about 5-20 min [0060], which overlaps with recited heat-treating conditions of 400 to 430 °C for 25 to 40 minutes. Furthermore, examiner notes that all the disclosures in a reference must be evaluated for what they fairly teach one of ordinary skill in the art even though the art teachings relied upon are phrased in terms of a non-preferred embodiment or even as being unsatisfactory for the intended purpose. In re Boe, 148 USPQ 507 (CCPA 1966). “A non-preferred portion of a reference is just as significant as the preferred portion in assessing the patentability of claims.” In re Nehrenberg, 126 USPQ 383 (CCPA 1960).
Applicant also argues:
In fact, in the present invention, compliance with both the temperature range of 400°C to 430°C and the time interval of 25 to 40 minutes advantageously enables the obtaining of desired mechanical properties of the root canal instrument according to the present invention.
Table 2 below lists data from a cyclic fatigue test (indicating service life - the higher, the better) and a bending test (indicating bending moment - the smaller, the better) performed in accordance with DIN EN ISO 3630-1 on working areas of endodontic files made of a NiTi alloy, as defined in claim 1.
In response, examiner notes that the features upon which Applicant relies (i.e., cyclic fatigue strength or bending moment) are not recited in the rejected claim(s) and thus, the argument does not appear to be commensurate with the scope of the claim. Moreover, the working area heat-treated under conditions of 400 to 430 °C for 25 to 40 minutes in Ammon are substantially same as claimed. Consequently, one of ordinary skill in the art would reasonably expect to have the same mechanical properties resulting from the heat treatment in Ammon, absent any unexpected results, which would require objective evidence. The arguments of counsel cannot take the place of evidence in the record. Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need and inoperability of the prior art (see MPEP 716.01(c)).
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.
Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVANG R PATEL whose telephone number is (571) 270-3636. The examiner can normally be reached on Monday-Friday 8am-5pm, EST.
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/DEVANG R PATEL/
Primary Examiner, AU 1735