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 .
Detailed Action
This is in response to the amendment filed 06/09/2029
Allowable Subject Matter
Claim 3 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.
Claim 3 recites the circumferential slits are arranged such that no longitudinal spine etends through the flexible section.
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.
Claim(s) 1-2, 4-13, 15, 16, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013172970 (Gupta) in view of U.S. Patent Publication Number 2009/0018565 (To et al.)
Regarding claim 1, 6, 11 Gupta discloses as shown in Figures 1, 5A, 6, 7a, 7b an atherectomy catheter capable of use in a vessel comprising: a catheter body a fixed jog section (fixed jog 333, see paragraph [00061]) having a fixed curvature; a nosecone (nosecone 305, see paragraph [00061]) attached to a distal end of the catheter body and; and a driveshaft (drive shaft 113, see paragraph [0044]) configured to rotate within the catheter body and to move distally and proximally within the catheter body, wherein a distal end of the driveshaft includes an annular cutter, a flexible section (flexible section, see paragraph [0063]) having a greater flexibility than a remainder of the catheter body, a cutting window (cutting window 307, see paragraph [00061]); and an annular cutter (cutter 303, see paragraph [00061]) configured to rotate with respect to the catheter body and positioned within the cutting window, wherein the nosecone is configured to pivot with respect to the catheter body.
Gupta fails to disclose the flexible section includes circumferential slits that are configured to allow the flexible section to passively bend in multiple directions.
To et al., from the same field of endeavor teaches a similar catheter and method as shown in Figure 8A where a flexible section includes a plurality of circumferential slits (openings 252, see paragraph [0217]) that allow the flexible section to passively bend in multiple directions (bend in at least one direction and then return to the same position which would necessarily be two directions).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Gupta by substituting the flexible section disclosed by Gupta for the one disclosed by To et al. because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regrading claim 2, Gupta in view of To et al. fail to disclose the circumferential slits are arranged in rows in a circumferentially offset pattern.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify device disclosed by Gupta in view of To et al. by rearranging the location of the circumferential slits disclosed by Gupta in view of To et al. such that the circumferential slits are arranged in rows in a circumferentially offset pattern because it would only require a rearrangement of parts without changing how the device operates (slits would still allow the jog to bend). See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
Regarding claim 4, Gupta fail to disclose wherein the fixed jog section includes a second set of circumferential slits.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the device disclosed by Gupta in view of To el. by including a second set of circumferential slit because it would only require the duplication of parts without producing a new or unexpected result. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)
Regarding claim 5, Gupta discloses the jog section includes a longitudinal spine (stiffening member 777a, see paragraph [00067]).
Regarding claim 7, Gupta discloses wherein the fixed jog section form an angle ranging from 120degrees to 175 degrees in the catheter body. See paragraph [0063].
Regarding claim 8, Gupta in view of To et al. discloses an annular spine (generally indicated as A) between the fixed jog section and the flexible section.
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Regarding claims 9, 10, Gupta discloses wherein the fixed jog section has an s-shape, wherein the fixed jog section has a c-shape (half of an S is a c-shape). See paragraph [0062].
Regarding claim 12 Gupta fails to disclose wherein the fixed jog section is proximal to the flexible section.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the device disclosed by Gupta by rearranging the location of the flexible section such that the fixed jog section is proximal to the flexible section because it would only require a rearrangement of parts without changing how the device operates (catheter body would still bend). See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
Regarding claim 13, Gupta discloses wherein the fixed jog section is distal to the flexible section. See paragraph [0063].
Regarding claims 15, 18 Gupta discloses as shown in Figures 1, 5A, 6 a method of performing atherectomy comprising: inserting an atherectomy catheter into a vessel, the atherectomy catheter including a catheter body having a fixed jog section having a fixed curvature (cutter section 335, see paragraph [00062]), a flexible section (flexible section, see paragraph [0063]) having a greater flexibility than the fixed job section, a nosecone (nosecone 305, see paragraph [00061]) attached to a distal end of the catheter body, a driveshaft (drive shaft 113, see paragraph [0044]) configured to rotate within the catheter body and to move distally and proximally within the catheter body, wherein a distal end of the driveshaft includes an annular cutter and an annular cutter (cutter 303, see paragraph [00061]) within a window of the nosecone; positioning the catheter body within the vessel such that the curved portion urges the annular cutter against a wall of the vessel; and rotating the annular cutter against the wall of the vessel. See paragraph [00061].
Gupta fails to disclose the flexible section includes circumferential slits that are configured to allow the flexible section to passively bend in multiple directions.
To et al., from the same field of endeavor teaches a similar catheter and method as shown in Figure 8A where a flexible section includes a plurality of circumferential slits (openings 252, see paragraph [0217]) that allow the flexible section to passively bend.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Gupta by substituting the flexible section disclosed by Gupta for the one disclosed by To et al. because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claim 16, Gupta discloses comprising moving the annular cutter distally to pack tissue into the nosecone. See paragraph [00046].
Regarding claim 19, Gupta discloses wherein the fixed jog section form an angle ranging from 120degrees to 175 degrees in the catheter body. See paragraph [0063].
Regarding claim 20, Gupta is discloses wherein the fixed jog is adjacent (interpreted as not distant or nearby which is its plain and ordinary meaning according to webster’s dictionary and not inconsistent with the specification) to the flexible section. See paragraph [0063].
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013172970 (Gupta) in view of U.S. Patent Publication Number 2009/0018565 (To et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2006/0229646 (Sparks)
Regarding claim 14, Gupta fails to disclose wherein the fixed jog section and the flexible section are laminated in a polymer.
Sparks, from the same field of endeavor taches a similar catheter as shown in Figure 1, where sections of the catheter are laminated in a polymer. See paragraph [0040].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter disclosed by Gupta by substituting the material of the fixed jog section and the flexible section for the sections of the catheter laminated in a polymer taught by Sparks because it would only require a simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013172970 (Gupta) in view of U.S. Patent Publication Number 2004/0167553 (Simpson et al.)
Regarding claim 17, Gupta fails to disclose removing the catheter body from the vessel with tissue packed within the nosecone.
Simpson et al., from the same field of endeavor teaches a similar method of performing atherectomy as shown in Figure 1, which includes the step of removing the catheter body from the vessel with tissue packed within the nosecone in order to empty the catheter when it is full. See paragraph [0109].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify method disclosed by Gupta to include the step of removing the catheter body from the vessel with tissue packed within the nosecone.
Response to Arguments
Applicant's arguments filed 06/09/2026 have been fully considered but they are not persuasive. The applicant argues To fails to teach of suggest wherein the circumferential slits are arranged in rows in circumferentially offset pattern because To discloses the structure is actively actuated.
In response, the Office respectfully disagrees. The claims do not exclude active actuation and the claims do not require a structure that provides for passive actuation. Even if they did, the structure that the applicant describes as allowing passive actuation is circumferential slits which is exactly what To discloses.
The applicant a further argues bending in one direction and returning to the original positions is not the same as bending in two directions as recited in the claim.
In response, the Office respectfully disagrees. The claims do not define the directions. Bending the jog section bends it in at least a downward direction. Releasing the bend means it bends in an upward direction. This is two directions are defined by the claim and meets the literal definition of “multiple directions” as recited in the claim.
The applicant further argues that it would not be obvious to rearrange the locations of the slits such that they are arranged in a circumferentially offset pattern because the locations of the slits in To are not arbitrary. In response, the Office respectfully disagrees. To does not disclose the location of the slits is critical or that an alternative arrangement would render the device inoperable. In fact, To discloses in paragraph [0333] that the illustrated embodiments are only illustrative.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is (571)270-1965. The examiner can normally be reached on Monday – Friday, 9:30 am – 6 pm.
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/RICHARD G LOUIS/ Primary Examiner, Art Unit 3771
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