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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/13/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 8/13/2025. As directed by the amendment: claims 1, 11 and 15 have been amended; no claims have been cancelled; and no claims have been added. Thus, claims 1-20 are presently pending in this application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Barath (US 5797935 A) in view of Bocino et al. (US 20130116655 A1).
Regarding claim 1, Barath discloses an exoskeleton device (Fig. 1) configured for assembly with an elongated medical instrument (34), comprising:
a sleeve (16/20/22) with a configuration that:
slides onto, surrounds, and while unexpanded covers an entirety of a distal portion (Part of 34 that 16/20/22 covers) of an elongated medical instrument (34) without extending proximally beyond the distal portion of the elongated medical instrument (Figs. 3 and 5); and
remains on the elongated medical instrument during introduction of the elongated medical instrument into a body of a subject, use of the elongated medical instrument, and withdrawal of the elongated medical instrument from the body of the subject (Col 5, lines 21-38); and
is expandable (Figs. 5-6).
Barath is silent regarding
the sleeve with a configuration that is expandable to vary an orientation of a blade of the sleeve and to move the blade radially outward.
In analogous art, Bacino teaches a sleeve (1020) with a configuration that is expandable to vary an orientation of a blade (1026) of the sleeve and to move the blade radially outward (Figs. 10C-10D).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sleeve of Barath to incorporate the teachings of Bacino to incorporate being expandable to vary an orientation of a blade of the sleeve and to move the blade radially outward in order to vary the amount of “abrasion” provided by a blade to a surrounding tissue(s) during inflation (Paragraph [0107]).
Regarding claim 2, Barath in view of Bocino disclose the exoskeleton device of claim 1, wherein the sleeve comprises an elongated tube (Fig. 1, Barath).
Regarding claim 3, Barath in view of Bocino disclose the exoskeleton device of claim 1, further comprising: a collar (40/42, Barath) that circumferentially surrounds and engages a location along a length of the elongated medical instrument (Col 4, lines 10-13, Barath).
Regarding claim 4, Barath in view of Bocino disclose the exoskeleton device of claim 3, wherein the collar holds the sleeve in place on the distal portion of the elongated medical instrument (Col 4, lines 10-13, Barath).
Regarding claim 5, Barath in view of Bocino disclose the exoskeleton device of claim 3, wherein the collar is located at or adjacent to a proximal end of the sleeve (Col 4, lines 3-5, Barath).
Regarding claim 6, Barath in view of Bocino disclose the exoskeleton device of claim 3, comprising a plurality of collars (40/42, Barath).
Claims 1-2, 7-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Spears (US 4799479 A) in view of Giasolli et al. (US 20170100570 A1) further in view of Bocino et al. (US 20130116655 A1).
Regarding claim 1, Spears discloses an exoskeleton device (Fig. 8) configured for assembly with an elongated medical instrument (34), comprising:
a sleeve (72) with a configuration that:
surrounds and while unexpanded covers an entirety of a distal portion (Part of balloon that 72 covers) of an elongated medical instrument without extending proximally beyond the distal portion of the elongated medical instrument (Fig. 8, Col 7, lines 47-53, Col 10, lines 16-23); and
remains on the elongated medical instrument during introduction of the elongated medical instrument into a body of a subject, use of the elongated medical instrument, and withdrawal of the elongated medical instrument from the body of the subject (Col 7, lines 47-53, Col 10, lines 16-23, Claims 46 and 57, because the meshwork of electrical wires 72 is provided on the balloon, the wires would remain on the elongated medical instrument during introduction of the elongated medical instrument into a body of a subject, use of the elongated medical instrument, and withdrawal of the elongated medical instrument from the body of the subject); and
is expandable (Figs. 1B-1C and 8).
Spears is silent regarding
the sleeve with a configuration that slides onto the distal portion of the elongated medical instrument and is expandable to vary an orientation of a blade of the sleeve and to move the blade radially outward.
In analogous art, Giasolli teaches a sleeve (10/28, Paragraph [0101]) with a configuration that slides onto a distal portion of an elongated medical instrument (20, Figs. 1A-1B, Paragraphs [0101] and [0106]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sleeve of Spears to incorporate the teachings of Giasolli to incorporate having a configuration that slides onto the distal portion of the elongated medical instrument in order to attach the sleeve to the elongated medical instrument (Paragraph [0106], Giasolli).
Spears in view of Giasolli are silent regarding
the sleeve with a configuration that is expandable to vary an orientation of a blade of the sleeve and to move the blade radially outward
In analogous art, Bacino teaches a sleeve (1020) with a configuration that is expandable to vary an orientation of a blade (1026) of the sleeve and to move the blade radially outward (Figs. 10C-10D).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sleeve of Spears in view of Giasolli to incorporate the teachings of Bacino to incorporate being expandable to vary an orientation of a blade of the sleeve and to move the blade radially outward in order to vary the amount of “abrasion” provided by a blade to a surrounding tissue(s) during inflation (Paragraph [0107]).
Regarding claim 2, Spears in view of Giasolli further in view of Bacino disclose the exoskeleton device of claim 1, wherein the sleeve comprises an elongated tube (Fig. 8, Spears).
Regarding claim 7, Spears in view of Giasolli further in view of Bacino disclose the exoskeleton device of claim 1, further comprising:
a tether (Image 1) extending proximally from the sleeve (Fig. 8, Spears), positionable along a length of the elongated medical instrument (Fig. 8, Spears).
Image 1:
PNG
media_image1.png
330
728
media_image1.png
Greyscale
Regarding claim 8, Spears in view of Giasolli further in view of Bacino disclose the exoskeleton device of claim 7, wherein the tether enables communication between a proximal end of the tether and the sleeve (Fig. 8, Col 10, lines 16-23, Spears).
Regarding claim 10, Spears in view of Giasolli further in view of Bacino disclose the exoskeleton device of claim 8, wherein the tether enables communication of signals between the proximal end of the tether and the sleeve (Fig. 8, Col 10, lines 16-23, Spears).
Claims 1-2 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Racchini et al. (US 5458568 A) in view of Conoscenti et al. (US 4886496 A) further in view of Bocino et al. (US 20130116655 A1).
Regarding claim 1, Racchini discloses an exoskeleton device (Fig. 6) configured for assembly with an elongated medical instrument (11), comprising:
a sleeve (44) with a configuration that:
surrounds and while unexpanded covers an entirety of a distal portion (Part of 11 that 44 covers) of an elongated medical instrument (11) without extending proximally beyond the distal portion of the elongated medical instrument (Fig. 6); and
remains on the elongated medical instrument during introduction of the elongated medical instrument into a body of a subject, use of the elongated medical instrument, and withdrawal of the elongated medical instrument from the body of the subject (Fig. 6, Col 8, lines 5-9); and
is expandable (Figs. 1-2 and 8).
Racchini is silent regarding
the sleeve with a configuration that slides onto the distal portion of the elongated medical instrument and is expandable to vary an orientation of a blade of the sleeve and to move the blade radially outward.
In analogous art, Conoscenti teaches a sleeve (12) with a configuration that slides onto a distal portion of an elongated medical instrument (10, Col 4, lines 60-64).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sleeve of Racchini to incorporate the teachings of Conoscenti to incorporate having a configuration that slides onto the distal portion of the elongated medical instrument in order to attach the sleeve to the elongated medical instrument (Cols 4-5, lines 60-9, Conoscenti).
Racchini in view of Conoscenti are silent regarding
the sleeve with a configuration that is expandable to vary an orientation of a blade of the sleeve and to move the blade radially outward.
In analogous art, Bacino teaches a sleeve (1020) with a configuration that is expandable to vary an orientation of a blade (1026) of the sleeve and to move the blade radially outward (Figs. 10C-10D).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sleeve of Spears in view of Giasolli to incorporate the teachings of Bacino to incorporate being expandable to vary an orientation of a blade of the sleeve and to move the blade radially outward in order to vary the amount of “abrasion” provided by a blade to a surrounding tissue(s) during inflation (Paragraph [0107]).
Regarding claim 2, Racchini in view of Conoscenti further in view of Bacino disclose the exoskeleton device of claim 1, wherein the sleeve comprises an elongated tube (Fig. 6, Racchini).
Regarding claim 7, Racchini in view of Conoscenti further in view of Bacino disclose the exoskeleton device of claim 1, further comprising:
a tether (45) extending proximally from the sleeve (Fig. 6 Racchini), positionable along a length of the elongated medical instrument (Fig. 6, Col 11, lines 39-40 Racchini).
Regarding claim 8, Racchini in view of Conoscenti further in view of Bacino disclose the exoskeleton device of claim 7, wherein the tether enables communication between a proximal end of the tether and the sleeve (Col 11, lines 37-54 Racchini).
Regarding claim 9, Racchini in view of Conoscenti further in view of Bacino disclose the exoskeleton device of claim 8, wherein the tether enables communication of fluids between the proximal end of the tether and the sleeve (Col 11, lines 37-54 Racchini).
Response to Arguments
Applicant's arguments filed 7/14/2025 have been fully considered but they are not persuasive.
In response to applicant's arguments, on page 7, that Barath does not teach a balloon-activated force concentrator 10 that, while unexpanded, covers an entirety of an angioplasty balloon 34, the examiner respectfully disagrees. As shown in Figs. 3-6, Fig. 3 shows the balloon-activated force concentrator 10 covering an entirety of the angioplasty balloon 34 and Fig. 5 shows the angioplasty balloon is in an unexpanded configuration. One of ordinary skill in the art, in view of Figs. 3-6, would understand that an entirety of an angioplasty balloon 34 would be covered by the balloon-activated force concentrator 10 while unexpanded.
In response to applicant's arguments, on pages 7-8, that Bocino does not teach a sleeve that includes elongated blades with orientations that vary as the sleeve expands, the examiner respectfully disagrees. Merriam-webster defines “blade” as being “the cutting part of an implement”. Bacino teaches in that the rigid elements can be configured to be rough and/or sharp and the rigid elements 1026 are pivoted outward as a second inflated state, the amount of abrasion can be varied during inflation, in Paragraphs [0107] and [0108], therefore teaching a cutting part of an implement, i.e. a blade. The claims require that the sleeve has a configuration that is expandable to vary an orientation of a blade of the sleeve. Figs. 2B(1)-2B(3) teaches a balloon 200, underlying a template 220, in a deflated state, a first inflated state, and a second inflated state. As the balloon 200 is inflated, the template 220 also expands, and at the expansion state of the template 220 shown in Figs. 2B(3) and 10D, the orientation of the rigid elements 1026 change. The applicant further argues that the cylindrical template 1020 does not cover an entirety of the balloon 1010, however the examiner is not relying on Bocino to teach this limitation.
In response to applicant's arguments, on page 9, that Spears does not teach the meshwork of electrical wires 72 is an exoskeleton device configured for assembly with an elongated medical instrument or that the meshwork of electrical wires 72 slides onto and surrounds a distal portion of an elongated medical element, the examiner respectfully disagrees. Spears teaches that the outside of the wall is provided with the meshwork of electrical wires 72 and just because the balloon 34 is provided with the meshwork of electrical wires 72 does not mean it cannot be configured for assembly with the balloon or that it cannot be modified to teach the electrical wires 72 be slid onto the distal portion of the balloon. With respect to arguments regarding Bocino, see above.
In response to applicant's arguments, on pages 10-11, that Racchini does not teach the an exoskeleton device, the examiner respectfully disagrees. Racchini teaches a balloon 44 that expands, therefore teaching an expandable sleeve. With respect to arguments regarding Bocino, see above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG-VAN N TRINH whose telephone number is (571)272-8039. The examiner can normally be reached Monday-Friday 9:15-5:45 ET.
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, Chelsea Stinson can be reached at (571) 270-1744. 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.
/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
Prosecution Insights