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
Claims 1-15 are pending in the application. Claims 5, 6, 9, 10, and 15 have been amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/25/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the features of claim 12 (a varying diameter drive shaft) in combination with the features of claim 13 (the connecting portion of the varying diameter draft shaft inserted into the proximal hollow cavity section through a proximal opening of the rotating abrasive head, the proximal opening having a radial dimension smaller than or equal to a diameter of a proximal end of the connecting portion) must be shown or the feature(s) canceled from the claim(s). Additionally, the “connecting portion has a diameter gradually increasing and then gradually decreasing from proximal to distal in the axial direction” (claim 14) must be shown or the feature(s) canceled from the claim(s). Further, the “drive device” (claim 15) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 5-8 and 12-14 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.
Claim 5 recites the limitation "the abrasive layer" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 6 recites the limitation "the axial direction" in line 3 and line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claims 7 and 8 are dependent on rejected claim 6, thus are also rendered indefinite. Appropriate correction is required.
Claim 7 also recites the limitation "the distal portion" in lines 3, 5, and 7. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 7 also recites the limitation "the proximal portion" in lines 4, 6, and 8. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 8 also recites the limitation "the distal portion" in lines 3 and 5. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 8 also recites the limitation "the intermediate portion" in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 8 also recites the limitation "the proximal portion" in lines 4 and 6. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 12 recites the limitation "the axial direction" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claims 13 and 14 are dependent on rejected claim 12, thus are also rendered indefinite. Appropriate correction is required.
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.
Claims 1-4, 6, 9, and 15 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cambronne (US 2014/0081298 A1).
Regarding claim 1, Cambronne discloses (Figures 1-8C) a rotational atherectomy device for use in vascular surgery, comprising a drive shaft (20) and a rotating abrasive head (28/28S), the drive shaft provided with a connecting portion (portion of drive shaft connected to the abrasive head 28S as shown in Figure 7) located at a distal end, the connecting portion connected to the rotating abrasive head, the rotating abrasive head and the drive shaft separately defining hollow cavities (19 and 23) axially extending therethrough, the hollow cavities configured for insertion of a guide body (15) therethrough, wherein a centroid of a structure consisting of the rotating abrasive head and the connecting portion connected thereto does not coincide with center axes (A) of the hollow cavities (Figure 3A; paragraph 0034).
Regarding claim 2, Cambronne discloses (Figure 7) a diameter of a distal portion (40S) of the rotating abrasive head gradually increases from distal to proximal in an axial direction, and an outer surface of the distal portion of the rotating abrasive head is coated with an abrasive layer (24; paragraph 0049).
Regarding claim 3, Cambronne discloses (Figure 7) a diameter of a proximal portion (30S) of the rotating abrasive head gradually decreases from distal to proximal in the axial direction, and an outer surface of the proximal portion of the rotating abrasive head is coated with the abrasive layer (24; paragraph 0046), and/or an outer surface of an intermediate portion (35S) of the rotating abrasive head between the distal portion and the proximal portion is coated with the abrasive layer (24; paragraph 0046).
Regarding claim 4, Cambronne discloses (Figure 7) that the intermediate portion (35S) has a constant diameter, or wherein a diameter of the intermediate portion (35S) gradually increasing and then gradually decreasing from distal to proximal in the axial direction (paragraph 0048).
Regarding claim 6, Cambronne discloses (Figure 7) a diameter of the rotating abrasive head gradually decreases distally (at 40S) in the axial direction and the diameter of the rotating abrasive head gradually decreases proximally (at 30S) in the axial direction.
Regarding claim 9, Cambronne discloses (Figures 2 and 7) the guide body (15), wherein the rotating abrasive head and the drive shaft are rotatable and axially movable relative to the guide body (paragraph 0029).
Regarding claim 15, Cambronne discloses (Figure 1) a rotational atherectomy apparatus comprising a drive device (turbine/similar rotational drive mechanism, paragraph 0030) and the rotational atherectomy device of claim 1 (see rejection of claim 1 above), the drive device coupled to the drive shaft in the rotational atherectomy device and configured to actuate rotation of the rotational atherectomy device (paragraph 0030).
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, 6, 7, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Wasdyke et al. (US 2016/0022307 A1) (“Wasdyke”) in view of Clement et al. (US 5,681,336) (“Clement”).
Regarding claim 1, Wasdyke discloses (Figures 1-3) a rotational atherectomy device for use in vascular surgery, comprising a drive shaft (24) and a rotating abrasive head (20), the drive shaft provided with a connecting portion (portion of drive shaft connected to abrasive head, Figures 2 and 3) located at a distal end, the connecting portion connected to the rotating abrasive head, the rotating abrasive head and the drive shaft separately defining hollow cavities (60 and 62, 64) axially extending therethrough, the hollow cavities configured for insertion of a guide body (50) therethrough.
Wasdyke fails to disclose a centroid of a structure consisting of the rotating abrasive head and the connecting portion connected thereto does not coincide with center axes of the hollow cavities.
In the same field of endeavor, Clement teaches (Figure 4) that it is known in the art for a centroid of a structure consisting of a rotating abrasive head and a connecting portion of a drive shaft to not coincide with center axes of hollow cavities formed separately by the rotating abrasive head and the drive shaft. Clement teaches that this forms a structure that is asymmetrical, which creates a passageway having a diameter greater than the maximum diameter of the structure (Column 4, lines 32-41).
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 structure disclosed by Wasdyke to have a centroid that does not coincide with center axes of the hollow cavities, as taught by Clement. This modification would provide an asymmetrical structure that creates a passageway having a diameter greater than the maximum diameter of the structure when rotated (Clement, Column 4, lines 32-41).
Regarding claim 6, Wasdyke as modified by Clement teaches (Wasdyke, Figures 2 and 3; Clement, Figure 4) that a diameter of the rotating abrasive head gradually decreases distally in the axial direction and the diameter of the rotating abrasive head gradually decreases proximally in the axial direction.
Regarding claim 7, Wasdyke as modified by Clement teaches (Wasdyke, Figure 2) that a minimum diameter of the distal portion (D2 at tip 70) of the rotating abrasive head (20) smaller than a minimum diameter (see Figure 2 annotated below) of the proximal portion of the rotating abrasive head.
PNG
media_image1.png
446
682
media_image1.png
Greyscale
Regarding claim 10, Wasdyke as modified by Clement teaches (Wasdyke, Figures 2 and 3) that the hollow cavity of the rotating abrasive head (20) consists of a distal hollow cavity section (62, 64) and a proximal hollow cavity section in communication with each other, the distal hollow cavity section having a diameter matching a diameter of the guide body (Figure 3), the proximal hollow cavity section having a diameter (D5, see Figure 2 annotated below) greater than the diameter of the distal hollow cavity section, the proximal hollow cavity section secured to the connecting portion.
PNG
media_image2.png
446
682
media_image2.png
Greyscale
Regarding claim 11, Wasdyke as modified by Clement teaches (Wasdyke, Figures 2 and 3) the drive shaft (24) is generally a hollow tubular structure with a constant diameter, and wherein a center axis of the drive shaft is coincident with a center axis of the guide body (Figure 3).
Claims 1, 10, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Shturman et al. (US 6,217,595 B1) (“Shturman”) in view of Shturman et al. (US 2003/0125756 A1) (“Shturman ‘756”)
Regarding claim 1, Shturman discloses (Figures 1, 4, 5) a rotational atherectomy device for use in vascular surgery, comprising a drive shaft (20’) and a rotating abrasive head (34’), the drive shaft provided with a connecting portion (32) located at a distal end, the connecting portion connected to the rotating abrasive head, the rotating abrasive head and the drive shaft separately defining hollow cavities axially extending therethrough (see Figure 4 annotated below), the hollow cavities configured for insertion of a guide body (14) therethrough.
PNG
media_image3.png
472
766
media_image3.png
Greyscale
Shturman fails to disclose a centroid of a structure consisting of the rotating abrasive head and the connecting portion connected thereto does not coincide with center axes of the hollow cavities. However, Shturman discloses that the outer layer has an increased diameter along at least part of its length to define an enlarged diameter segment of the drive shaft. The precise shape of this enlarged diameter segment of the drive shaft can be varied (Column 2, lines 54-58).
In the same field of endeavor, Shturman ‘756 teaches (Figures 1A-48) that it is known in the art for a centroid of a structure consisting of a rotating abrasive head (22) and a connecting portion (34) of a drive shaft (14) to not coincide with center axes of hollow cavities formed separately by the rotating abrasive head and the drive shaft. Shturman teaches that this forms an eccentric structure. When placed within an artery against stenotic tissue and rotated at sufficiently high speeds (e.g. in the range of about 40,000 rpm to about 200,000 rpm) the eccentric nature of the structure causes its abrasive segment to rotate in such a fashion as to open the stenotic lesion to a diameter substantially larger than the maximum diameter of the structure (paragraph 0009).
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 structure disclosed by Shturman to be shaped to have a centroid that does not coincide with center axes of the hollow cavities, as taught by Shturman ‘756. Shturman discloses that the precise shape of a structure consisting of the rotating abrasive head and the connecting portion connected thereto can be varied (Shturman, Column 2, lines 54-58). This modification would provide an eccentrically shaped structure that creates a passageway having a diameter greater than the maximum diameter of the structure when rotated at sufficiently high speeds (Shturman ‘756, paragraph 0009).
Regarding claim 10, Shturman as modified by Shturman ‘756 teaches (Shturman, Figure 4 annotated below) that the hollow cavity of the rotating abrasive head consists of a distal hollow cavity section (within 36’) and a proximal hollow cavity section in communication with each other, the distal hollow cavity section having a diameter matching a diameter of the guide body (14), the proximal hollow cavity section having a diameter greater than the diameter of the distal hollow cavity section, the proximal hollow cavity section secured to the connecting portion (32).
PNG
media_image4.png
472
766
media_image4.png
Greyscale
Regarding claim 12, Shturman as modified by Shturman ‘756 teaches (Shturman, Figures 4 and 5) that the drive shaft (20’) is a hollow tubular structure with a varying diameter, wherein the connecting portion (32) has a diameter increasing from proximal to distal in the axial direction, and wherein the drive shaft further has a constant-diameter section (22) joined to a proximal end of the connecting portion, the constant-diameter section having a center axis coincident with a center axis of the guide body (14; Shturman, Figure 1).
Regarding claims 13 and 14, Shturman as modified by Shturman ‘756 teaches that the connecting portion is configured to be asymmetric about the center axis of the constant-diameter section (as modified by Shturman ‘756 above). However, the combined teaching above fails to teach that the connecting portion is inserted into the proximal hollow cavity section through a proximal opening of the rotating abrasive head, the proximal opening having a radial dimension smaller than or equal to a diameter of proximal end of the connecting portion.
Shturman ‘756 further teaches that the rotating abrasive head (22) is formed as a sleeve or crown (22) mounted on the connecting portion (34). Shturman ‘756 teaches (Figures 15-41) that the connecting portion (34) is inserted into the proximal hollow cavity section through a proximal opening of the rotating abrasive head (22), the proximal opening having a radial dimension equal to a diameter of proximal end of the connecting portion (paragraph 0079).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the rotating abrasive head taught by Shturman in view Shturman ‘756 above to be formed as an abrasive sleeve or crown that is mounted on the connecting portion, wherein the connecting portion is inserted into the proximal hollow cavity section through a proximal opening of the rotating abrasive head, the proximal opening having a radial dimension smaller than or equal to a diameter of proximal end of the connecting portion, as further taught by Shturman ‘756. This modification would form a rotating abrasive head that is less difficult and expensive to form in comparison to applying abrasive material directly to wire turns (Shturman ‘756, paragraph 0009). This modification would provide a rotating abrasive head in the form of a sleeve or crown that is locked in place relative to the connecting portion such that it cannot move axially or rotationally relative to the connecting portion during operation of the device (Shturman ‘756, paragraph 0049).
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Cambronne (US 2014/0081298 A1) in view of Shturman (US 5,314,438).
Regarding claim 5, Cambronne discloses (Figure 7) that the abrasive layer (24) has a thickness. However, Cambronne fails to explicitly disclose that the thickness is 20-120 µm.
In the same field of endeavor, Shturman teaches (Figures 2-8) an abrasive head that is coated with an abrasive layer (44, 48). Shturman teaches that the abrasive layer has a thickness of 15 µm – 35 µm (Column 11, lines 30-34).
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 thickness of the abrasive layer disclosed by Cambronne to be 20-120 µm, as taught by Shturman, 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Applicant appears to have placed no criticality on the claimed range, indicating a thickness of the abrasive layer “may be in the range of 20-120 µm, such as 20 µm, 40 µm, 50 µm or 100 µm” (see page 16 of Specification).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wasdyke et al. (US 2016/0022307 A1) (“Wasdyke”) in view of Clement et al. (US 5,681,336) (“Clement”) as applied to claim 6 above, and further in view of Cambronne (US 2014/0081298 A1).
Regarding claim 8, Wasdyke as modified by Clement teaches the invention substantially as claimed. However, the combined teaching fails to teach the rotating abrasive head comprises at least one of:
a diameter of the distal portion of the rotating abrasive head is 0.13-0.66 mm;
a maximum diameter of the intermediate portion between the proximal portion and the distal portion of the rotating abrasive head is 0.66-4.0 mm; and
a diameter of the proximal portion of the rotating abrasive head is 0.5-1.2 mm.
In the same field of endeavor, Cambronne teaches (Figure 7) a rotating abrasive head (28S) having a maximum diameter (D) of an intermediate portion (35S) between a proximal portion (30S) and a distal portion (40S) that is 1-3 mm (paragraph 0062).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a maximum diameter of the intermediate portion between the proximal portion and the distal portion of the rotating abrasive head taught by Wasdyke in view of Clement to be 0.66-4.0 mm, as taught by Cambronne, 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Applicant appears to have placed no criticality on the claimed range, indicating the maximum diameter of the intermediate portion of the rotating abrasive head “may be 0.66-4.0 mm, such as 0.66 mm, 1.25 mm, 2.0mm or 4.0 mm” (see page 18 of the Specification).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771