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 Amendment
In light of Applicant’s amendment, claim(s) 1 is/are amended. Claims 11-20 were previously withdrawn. Claims 1-10 are now pending examination.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the amendment to claim 1 requiring “a distal tapered surface that tapers distally from a midpoint and a proximal tapered surface that tapers proximally from the midpoint” overcomes the previous rejections as written. However, a new grounds of rejection is presented in view of Barry.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “drive assembly” in claim 9.
Claim 9 recites the limitation of a “drive assembly”. The term “assembly” is used as a substitute for “means” and is modified by functional language “adapted to translate relative to the advancer assembly”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “drive assembly” is “a motor, rubber feet, control electronics, drive circuitry, etc.” (Paragraph 0043; 0048) or equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barry (US 20020151917 A1) (noted on IDS).
Regarding claim 1, Barry discloses an atherectomy burr (28) adapted for use in an atherectomy system (20) (Figure 4-5), the atherectomy burr comprising:
an atherectomy burr body adapted to be secured to a driveshaft (26) (Figure 4-5; Paragraph 0028);
the atherectomy burr body having an outer surface defining a distal tapered surface (42) that tapers distally from a midpoint (62) and a proximal tapered surface (44) that tapers proximally from the midpoint (Figure 2; Paragraph 0029; 0031);
the distal tapered surface having a first abrasiveness (58) adapted for anterograde ablation (Figure 4-5; Paragraph 0031); and
the proximal tapered surface having a second abrasiveness (60) adapted for retrograde ablation (Figure 4-5; Paragraph 0031; 0037).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry in view of Dillard et al. (US 6569177 B1) (previously of record).
Regarding claim 2, Barry discloses the atherectomy burr of claim 1, but fails to explicitly disclose the first abrasiveness is greater than the second abrasiveness.
However, Dillard is directed to an atherectomy burr and teaches an atherectomy burr (200) body adapted to be secured to a driveshaft (20) (Figure 3; Col 4, line 37-39); the atherectomy burr body having an outer surface defining a distal tapered surface (240) and a proximal tapered surface (230) (Figure 3; Col 4, line 37-39); the distal tapered surface having a first abrasiveness (abrasiveness of 240) adapted for anterograde ablation (Col 4, lines 46-62); and the proximal tapered surface having a second abrasiveness (abrasiveness of 230) adapted for retrograde ablation (Col 4, lines 46-62) and the first abrasiveness is greater than the second abrasiveness (Col 4, lines 46-62).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Barry such that the first abrasiveness is greater than the second abrasiveness, as taught by Dillard, as both references and the claimed invention are directed to atherectomy burrs. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barry with the teachings of Dillard by incorporating the first abrasiveness is greater than the second abrasiveness in order to allow for varying degrees of aggression while abrading (Dillard Col 5, line 15-17).
Regarding claim 3, Barry discloses the atherectomy burr of claim 1, but fails to exclusively disclose wherein the distal tapered surface comprises abrasive particles having a first average particle size and the proximal tapered surface comprises abrasive particles having a second average particle size smaller than the first average particle size.
However, Dillard teaches an atherectomy burr (200) body adapted to be secured to a driveshaft (20) (Figure 3; Col 4, line 37-39); the atherectomy burr body having an outer surface defining a distal tapered surface (240) and a proximal tapered surface (230) (Figure 3; Col 4, line 37-39); the distal tapered surface having a first abrasiveness (abrasiveness of 240) adapted for anterograde ablation (Col 4, lines 46-62); and the proximal tapered surface having a second abrasiveness (abrasiveness of 230) adapted for retrograde ablation (Col 4, lines 46-62) and the distal tapered surface comprises abrasive particles (241) having a first average particle size and the proximal tapered surface comprises abrasive particles (231) having a second average particle size smaller than the first average particle size (Col 4, lines 46-62).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barry with the teachings of Dillard by incorporating the distal tapered surface comprises abrasive particles having a first average particle size and the proximal tapered surface comprises abrasive particles having a second average particle size smaller than the first average particle size in order to allow for varying degrees of aggression while abrading (Dillard Col 5, line 15-17).
Regarding claim 4, Barry discloses the atherectomy burr of claim 1, but fails to explicitly disclose wherein the distal tapered surface comprises abrasive particles having a first average exposed particle height and the proximal tapered surface comprises abrasive particles having a second average exposed particle height that is less than the first average exposed particle height.
However, Dillard teaches an atherectomy burr (200) body adapted to be secured to a driveshaft (20) (Figure 3; Col 4, line 37-39); the atherectomy burr body having an outer surface defining a distal tapered surface (240) and a proximal tapered surface (230) (Figure 3; Col 4, line 37-39); the distal tapered surface having a first abrasiveness (abrasiveness of 240) adapted for anterograde ablation (Col 4, lines 46-62); and the proximal tapered surface having a second abrasiveness (abrasiveness of 230) adapted for retrograde ablation (Col 4, lines 46-62) and wherein the distal tapered surface comprises abrasive particles (241) having a first average exposed particle height and the proximal tapered surface comprises abrasive particles (231) having a second average exposed particle height that is less than the first average exposed particle height (Col 4, lines 46-62).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barry with the teachings of Dillard by incorporating wherein the distal tapered surface comprises abrasive particles having a first average exposed particle height and the proximal tapered surface comprises abrasive particles having a second average exposed particle height that is less than the first average exposed particle height in order to allow for varying degrees of aggression while abrading (Dillard Col 5, line 15-17).
Regarding claim 5, Barry as modified by Dillard discloses the atherectomy burr of claim 4, but fails to explicitly disclose wherein the distal surface comprises abrasive particles having an average diameter embedded in a first thickness of overcoat and the proximal surface comprises abrasive particles having the same average diameter embedded in a second thickness of overcoat that is thicker than the first thickness of overcoat.
However, an alternative embodiment of Dillard (Fig 7) teaches wherein the distal surface (330) comprises abrasive particles (141) having an average diameter embedded in a first thickness of overcoat (342) and the proximal surface (340) comprises abrasive particles (141) having the same average diameter embedded in a second thickness of overcoat that is thicker than the first thickness of overcoat (Figure 7; Col 6, line 2-13).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barry as modified by Dillard by incorporating wherein the distal surface comprises abrasive particles having an average diameter embedded in a first thickness of overcoat and the proximal surface comprises abrasive particles having the same average diameter embedded in a second thickness of overcoat that is thicker than the first thickness of overcoat in order to form a less abrasive surface (Col 6, line 2-13).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry as modified by Dillard, as applied to claim 4 above, in view of Lee (EP 0486308 A2) (previously of record).
Regarding claim 6, Barry as modified by Dillard teaches the atherectomy burr of claim 4, wherein the distal surface comprises abrasive particles (241) having a first average diameter (Col 4, lines 46-62) and the proximal surface comprises abrasive particles (231) having a second average diameter (Col 4, lines 46-62) , where the second average diameter is less than the first average diameter (Col 4, lines 46-62).
However, Lee is directed to an abrasive (20) and teaches coating abrasive particles (24) with an overcoat (28) (Page 3 line 17-24). As a result of the modification to Dillard, the distal surface would comprise abrasive particles embedded in a thickness of overcoat and the proximal surface comprising abrasive particles embedded in the same thickness of overcoat.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Barry as modified by Dillard such that the abrasive particles are embedded in an overcoat, as taught by Lee, as both references and the claimed invention are directed to abrasive devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barry as modified by Dillard with the teachings of Lee by incorporating abrasive particles embedded in an overcoat in order to decrease friction between the abrasive grains and the workpiece being abraded and increase the lifespan of the abraded surface (Page 4 line 38, 42).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry in view of Barry et al. (US 6270509 B1) (noted on IDS) (herein after referred to as Barry ‘509).
Regarding claim 7, Barry discloses the atherectomy burr of claim 1, but fails to explicitly disclose wherein the distal tapered surface comprises abrasive particles having a first particle density value and the proximal tapered surface comprises abrasive particles having a second particle density value that is less than the first particle density value.
However, Barry ‘509 discloses an atherectomy burr (14) adapted for use in an atherectomy system, the atherectomy burr comprising: an atherectomy burr body (14) adapted to be secured to a driveshaft (Figure 1; Col 7, line 9-13); the atherectomy burr body having an outer surface (18+22) defining a distal tapered surface (18) and a proximal tapered surface (22) (Figure 1; the distal tapered surface having a first abrasiveness (19) adapted for anterograde ablation (Figure 1; Col 7, line 47-51); and the proximal tapered surface having a second abrasiveness (21) adapted for retrograde ablation (Figure 1; Col 8, line 4-6) (the dimples 21 are fully capable of providing at least some abrasiveness and would be fully capable of retrograde ablation); and wherein the distal tapered surface comprises abrasive particles (19) having a first particle density value and the proximal tapered surface comprises abrasive particles (21) having a second particle density value that is less than the first particle density value (Figure 1; Col 7, line 47-51; Col 8, line 4-6).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Barry such that wherein the distal tapered surface comprises abrasive particles having a first particle density value and the proximal tapered surface comprises abrasive particles having a second particle density value that is less than the first particle density value, as taught by Barry ‘509, as both references and the claimed invention are directed to atherectomy burrs. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barry with the teachings of Barry ‘509 by incorporating wherein the distal tapered surface comprises abrasive particles having a first particle density value and the proximal tapered surface comprises abrasive particles having a second particle density value that is less than the first particle density value in order to allow for varying levels of abrasion.
Regarding claim 8, Barry discloses the atherectomy burr of claim 1, but fails to explicitly disclose wherein the distal tapered surface comprises abrasive particles laid out in a constant pattern and the proximal tapered surface comprises abrasive particles laid out in a discontinuous pattern.
However, Barry ‘509 discloses an atherectomy burr (14) adapted for use in an atherectomy system, the atherectomy burr comprising: an atherectomy burr body (14) adapted to be secured to a driveshaft (Figure 1; Col 7, line 9-13); the atherectomy burr body having an outer surface (18+22) defining a distal tapered surface (18) and a proximal tapered surface (22) (Figure 1; the distal tapered surface having a first abrasiveness (19) adapted for anterograde ablation (Figure 1; Col 7, line 47-51); and the proximal tapered surface having a second abrasiveness (21) adapted for retrograde ablation (Figure 1; Col 8, line 4-6) (the dimples 21 are fully capable of providing at least some abrasiveness and would be fully capable of retrograde ablation); and wherein the distal tapered surface comprises abrasive particles (19) laid out in a constant pattern and the proximal tapered surface comprises abrasive particles (21) laid out in a discontinuous pattern (there is visibly space between consecutive dimples 21 whereas the grit 19 is closely packed together) (Figure 1).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barry with the teachings of Barry ‘509 by incorporating wherein the distal tapered surface comprises abrasive particles laid out in a constant pattern and the proximal tapered surface comprises abrasive particles laid out in a discontinuous pattern in order to allow for varying degrees of abrasion as needed, and Barry is silent to the patten of the abrasive grit.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prudnikov (US 20090105736 A1) (previously of record) in view of Barry.
Regarding claim 9, Prudnikov discloses an atherectomy system, comprising:
an advancer assembly (10) (as disclosed in Applicant’s spec, the advancer assembly can be a housing, which is consistent with handle 10 of Prudnikov) (Figure 1; Paragraph 0031);
a drive assembly (turbine) adapted to translate relative to the advancer assembly (Paragraph 0032) (As indicated above, the limitation “drive assembly” invokes 112(f). The corresponding structure in Prudnikov is a turbine, which is equivalent to a motor, as disclosed in the present disclosure.);
a knob (11) extending from the drive assembly such that translating the knob results in the drive assembly translating relative to the advancer assembly (Paragraph 0032);
a driveshaft (15+20) operably coupled with the drive assembly, the driveshaft translating relative to the advancer assembly as the drive assembly translates relative to the advancer assembly (Figure 1, 2; Paragraph 0032); and
an atherectomy burr (28); the atherectomy burr comprising:
an atherectomy burr body (28) adapted to be secured to a driveshaft (20) (Figure 1, 4; Paragraph 0033; 0035);
the atherectomy burr body having an outer surface defining a distal tapered surface (35+40) and a proximal tapered surface (30) (Figure 3; Paragraph 0033); and
the distal tapered surface having a first abrasiveness (37) adapted for anterograde ablation (Paragraph 0033).
Prudnikov fails to explicitly disclose the atherectomy burr of claim 1 such that a distal tapered surface that tapers distally from a midpoint and a proximal tapered surface that tapers proximally from the midpoint and the proximal tapered surface having a second abrasiveness adapted for retrograde ablation.
However, Barry teaches an atherectomy burr (28) adapted for use in an atherectomy system (20) (Figure 4-5), the atherectomy burr comprising: an atherectomy burr body adapted to be secured to a driveshaft (26) (Figure 4-5; Paragraph 0028); the atherectomy burr body having an outer surface defining a distal tapered surface (42) that tapers distally from a midpoint (62) and a proximal tapered surface (44) that tapers proximally from the midpoint (Figure 2; Paragraph 0029; 0031); the distal tapered surface having a first abrasiveness (58) adapted for anterograde ablation (Figure 4-5; Paragraph 0031); and the proximal tapered surface having a second abrasiveness (60) adapted for retrograde ablation (Figure 4-5; Paragraph 0031; 0037).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Prudnikov such that a distal tapered surface that tapers distally from a midpoint and a proximal tapered surface that tapers proximally from the midpoint and the proximal tapered surface having a second abrasiveness adapted for retrograde ablation, as taught by Barry, as both references and the claimed invention are directed to atherectomy systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Prudnikov with the teachings of Barry by incorporating a distal tapered surface that tapers distally from a midpoint and a proximal tapered surface that tapers proximally from the midpoint and the proximal tapered surface having a second abrasiveness adapted for retrograde ablation in order to allow ablation of particles on either side of the burr and allow for easier aspiration (Barry Paragraph 0037).
Regarding claim 10, Prudnikov further discloses wherein the atherectomy burr body defines an axially extending void (25) into which the driveshaft is adapted to be secured (Figure 2; Paragraph 0033; 0035).
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 ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DARWIN EREZO can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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