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 .
Response to Arguments
This Office action is in response to the applicant’s communication filed on 2/16/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see page 6, with respect to Applicant’s amendments to the specification made in view of the previous objections to the drawings have been fully considered and are persuasive. The previous objections to the drawings have been withdrawn.
Applicant's arguments, see pages 7-8, alleging that Nakatani fails to disclose the claimed ratio (DF:DS) (concentration DF of fluorine to concentration of DS of silicon) at the exterior surface of the DLC have been fully considered but they are not persuasive. As set forth below, Nakatani discloses the concentration of fluorine at the exterior surface being 1%-20% (see claim 9; [0018]; [0055]) and the concentration of silicon at the exterior surface being 0%-45% (see Applicant’s admission on page 8; [0012]-[0013]). Given the wide concentration range disclosed for each of fluorine and silicon, Nakatani teaches respective concertation ranges that at least partially overlap with the claimed ratio (i.e., a fluorine concertation of 20% and a silicon concertation of 10% (both concentrations within the disclosed ranges) would provide a ratio of 20:10 or 2:1), as set forth below. Additionally, Applicant alleges “the minimum silicon concentration at the surface is approximately 20% (see Figs. 3 and 4)”, wherein these figures merely reference a first embodiment that was not used in the previous rejections ([0034]-[0035]). For at least these reasons, Applicant’s arguments are not persuasive.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1 (and thereby dependent claims 2-20), the phrases "a ratio (DF:DS) … is from 1:1 to 90:1 … contains a greater amount of fluorine than silicon" renders the claim(s) indefinite because the claim scope ratio includes a 1:1 ratio (i.e., equal amounts fluorine and silicon) but then claim 1 also requires “a greater amount of fluorine than silicon” (at the same opposite side), thereby rendering the scope of the claim(s) unascertainable. These claim limitations appear to be contradictory and introduce ambiguity and/or uncertainty into the scope of the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claim(s) 1-3, 5-6, 8-9, 11-18 and 20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Nakatani et al. (US 2009/0209942).
Nakatani discloses a medical device having diamond-like thin film and methods of making comprising the following claim limitations:
(claim 1) A metal material for a medical device (see Abstract; [0001]), the metal material comprising a metal layer (see claims 12-13; [0020]-[0021]); and a diamond-like carbon layer (see Abstract; claim 1; [0001]) provided on the metal layer and containing fluorine (see claims 8-9 and 21; [0017]-[0018]; [0030]; [0055]; [0062]) and silicon in a single layer (see Abstract; claims 1-4 and 15-18; [0009]-[0013]; [0023]-[0027]; [0037]; [0040]; [0048]), wherein in the diamond-like carbon layer, a concentration of the fluorine at a surface at an opposite side from a side facing the metal layer is larger than a concentration of the fluorine at a surface at the side facing the metal layer, in a thickness direction of the diamond-like carbon layer (see claims 8 and 21; [0017]; [0030]; [0055]; fluorine concentration expressly increases continuously from the side closer to the medical device body toward the outer surface side); and in the diamond-like carbon layer, a concentration of the silicon at a surface at an opposite side from a side facing the metal layer is smaller than a concentration of the silicon at a surface at the side facing the metal layer, in a thickness direction of the diamond-like carbon layer (see claims 1-4 and 15-18; [0009]-[0013]; [0023]-[0027]; [0048]; silicon concentration expressly decreases continuously from the side closer to the medical device body toward the outer surface side);
(claim 2) wherein a total concentration of the fluorine contained in the diamond-like carbon layer is from 7 atom% to 10 atom% with respect to a total concentration of carbon, fluorine, and silicon (see claim 9; [0018]; [0055]; an atomic percentage of fluorine being in the range of 1 atom% to 20 atom% is expressly disclosed and fully encapsulates the claimed range) (applicant appears to have placed no criticality on the claimed range as paragraph [0049] indicates “an upper limit value or a lower limit value described in one numerical range may be replaced with an upper limit value or a lower limit value of another numerical range” (emphasis added); and see [0076]; indicating the fluorine concentration is only “preferably” found within the claimed range);
(claim 3) wherein a total concentration of the silicon contained in the diamond-like carbon layer is from 17 atom% to 25 atom% with respect to a total concentration of carbon, fluorine, and silicon (see claims 2 and 16; [0012]; [0025]-[0027]; [0048]; an atomic percentage of silicon being in the range of 0 atom% to 45 atom% is expressly disclosed and fully encapsulates the claimed range) (applicant appears to have placed no criticality on the claimed range as paragraph [0049] indicates “an upper limit value or a lower limit value described in one numerical range may be replaced with an upper limit value or a lower limit value of another numerical range” (emphasis added); and see [0082]; indicating the silicon concentration is only “preferably” found within the claimed range);
(claim 6) wherein a concentration of the fluorine contained in the diamond-like carbon layer gradually increases from the side facing the metal layer toward the opposite side from the side facing the metal layer in the thickness direction of the diamond-like carbon layer (see claims 8 and 21; [0017]; [0030]; [0055]; fluorine concentration expressly increases continuously from the side closer to the medical device body toward the outer surface side);
(claim 9) wherein the concentration of the silicon contained in the diamond-like carbon layer gradually decreases from the side facing the metal layer toward the opposite side from the side facing the metal layer in the thickness direction of the diamond-like carbon layer (see claims 1-4 and 15-18; [0009]-[0013]; [0023]-[0027]; [0048]; silicon concentration expressly decreases continuously from the side closer to the medical device body toward the outer surface side);
(claim 11) wherein the diamond-like carbon layer is provided as an outermost layer on the metal layer (see claims 1 and 15; only the DLC layer is applied to the outer surface of the medical device body);
(claim 12) wherein the metal layer contains at least one metal selected from the group consisting of titanium, nickel, cobalt, chromium, tantalum, platinum, gold, alloys thereof, and stainless steel (see claim 13; [0021]; [0044]; [0081]);
(claim 13) wherein the metal layer contains a nickel-titanium alloy, a cobalt-chromium alloy, or stainless steel (see claim 13; [0021]; [0044]; [0081]);
(claim 14) wherein the metal material is used in a stent (see claims 1 and 15; [0022]; [0032]-[0037]; [0043]-[0045]; [0057]; [0064]);
(claim 15) wherein the stent is a stent for a systemic blood vessel (see claims 1 and 15; [0022]; [0032]-[0037]; [0043]-[0045]; [0057]; [0064]; usage of the coating on stents for expansion within blood vessels is expressly disclosed with stents being well-known to be sized appropriately for the blood vessel of choice (e.g., from larger aortic stents to smaller coronary stents));
(claim 16) A medical device, comprising the metal material for a medical device according to claim 1 (see claims 1 and 15; [0022]; [0032]-[0037]; [0043]-[0045]; [0057]; [0064]; coating of a stent is expressly disclosed);
(claim 17) wherein the medical device is a stent (see claims 1 and 15; [0022]; [0032]-[0037]; [0043]-[0045]; [0057]; [0064]); and
(claim 18) wherein the stent is a stent for a lower limb blood vessel (see claims 1 and 15; [0022]; [0032]-[0037]; [0043]-[0045]; [0057]; [0064]; usage of the coating on stents for expansion within blood vessels is expressly disclosed with stents being well-known to be sized appropriately for the blood vessel of choice (e.g., from larger aortic stents to smaller coronary stents)).
Nakatani discloses a medical device having diamond-like thin film, wherein the exterior surface of the diamond-like thin film comprises a concentration of fluorine capable of ranging between 1%-20% (see claim 9; [0018]; [0055]) and a concentration of silicon capable of ranging between 0%-45% (see claim 4; [0025]-[0028]; [0048]).
Regarding claims 1 and 20, Nakatani does not explicitly disclose a ratio (DF:DS) of a concentration DF of the fluorine (between 16.1%-61.9%) with respect to a concentration DS of the silicon (between 0.7%-14.6%) at a surface of the diamond-like carbon layer at an opposite side from a side facing the metal layer is from 1:1 to 90:1, and a composition at the surface of the diamond-like carbon layer at the opposite side contains a greater amount of fluorine than silicon.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluorine concentration from anywhere in the range of 1%-20% to specifically 20%, and the silicon concentration from anywhere in the range of 0%-45% to specifically 10% (i.e., the ratio (DF:DS) being 20:10 or 2:1, and the respective concentration percentages reading on claim 20) since it has been held that “[i]n 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 Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed ranges (see paragraph [0049] indicating “an upper limit value or a lower limit value described in one numerical range may be replaced with an upper limit value or a lower limit value of another numerical range” (emphasis added); and see [0076]; [0082]; [0089]; indicating the respective concentrations and ratio are only “preferably” found within the claimed ranges).
Regarding claims 5 and 8, Nakatani discloses all the limitations of the claim except for, in the diamond-like carbon layer, a ratio Cf of the concentration of the fluorine at the surface at the opposite side from the side facing the metal layer with respect to the concentration of the fluorine at the surface at the side facing the metal layer satisfies a relationship 1<Cf≤155 (see claims 8-9 and 21; [0017]; [0030]; [0055]; fluorine concentration expressly increases continuously (in the range of 1 atom% to 20 atom%) from the side closer to the medical device body toward the outer surface side); and, in the diamond-like carbon layer, a ratio Cs of the concentration of the silicon at the surface at the opposite side from the side facing the metal layer with respect to the concentration of the silicon at the surface at the side facing the metal layer satisfies a relationship 0.015≤Cs<1 (see claims 3 and 17; [0009]-[0013]; [0023]-[0027]; [0040]; [0048]; silicon concentration expressly decreases continuously (in the range of not more than 50 atom%) from the side closer to the medical device body toward the outer surface side).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ratio Cf of the concentration of fluorine at the exterior surface compared to the inner surface to be 1<Cf≤155, and the ratio Cs of the concentration of silicon at the exterior surface compared to the inner surface to be 0.015≤Cs<1 since it has been held that “[i]n 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 Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed ranges (see paragraph [0049] indicating “an upper limit value or a lower limit value described in one numerical range may be replaced with an upper limit value or a lower limit value of another numerical range” (emphasis added); and see [0079]; [0085]; indicating the respective fluorine and silicon ratios are only “preferably” found within the claimed ranges).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Nakatani et al. (US 2009/0209942) in view of Suzuki et al. (US 2012/0177936).
Nakatani discloses a medical device having diamond-like thin film and methods of making comprising the following claim limitations:
(claim 19) A method of manufacturing a metal material for a medical device (see Abstract; claims 15-21), the method comprising forming a diamond-like carbon layer containing fluorine (see claim 21; [0017]-[0018]; [0030]; [0055]; [0062]) and silicon (see Abstract; claim 15; [0009]-[0013]; [0023]-[0027]; [0040]; [0048]) on a metal layer by vapor deposition ([0032]; [0047]-[0048]), by a vapor phase growth method using a mixed raw material obtained by mixing a silane compound ([0048]; [0061]; [0069]) and.
Nakatani, as applied above, discloses a medical device having diamond-like thin film and methods of making comprising all the limitations of the claim except for the device having a fluorine-containing aliphatic hydrocarbon being used as a raw material.
However, Suzuki teaches (see Fig. 1) a similar method of making a medical instrument having an outermost DLC layer (16, Fig. 1) comprising fluorine by means of a step of vapor deposition of a fluorine-containing aliphatic hydrocarbon therein. Accordingly, Suzuki teaches that it is known that a step of vapor deposition for incorporating fluorine into an outermost DLC layer on a medical device by means of either a gas containing carbon tetrafluoride (CF4) (see Nakatani, [0062]) or a gas containing a fluorine-containing aliphatic hydrocarbon ([0078]; [0088]; [0069]; [0096]-[0097]) are elements that are functional equivalents for providing fluorine into an outermost DLC layer on a medical device. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the fluorine-containing aliphatic hydrocarbon taught by Suzuki for the carbon tetrafluoride of Nakatani because both elements were known equivalents for providing fluorine into an outermost DLC layer on a medical device within the medical device and stent arts. The substitution would have resulted in the predictable results of providing fluorine into an outermost DLC layer on the medical device of Nakatani.
Conclusion
Applicant's amendment necessitated the new 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 Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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