DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The present application is a continuation application of U.S. patent application Ser. No. 17/207,011 filed Mar. 19, 2021, which is a continuation of U.S. patent application Ser. No. 15/997,335 filed Jun. 6, 2018, now U.S. Pat. No. 10,952,760 issued Mar. 23, 2021, which is a continuation application of U.S. patent application Ser. No. 14/986,357 filed Dec. 31, 2015, now U.S. Pat. No. 10,034,680 issued Jul. 31, 2018, which is a continuation application of U.S. patent application Ser. No. 13/823,060 filed Mar. 13, 2013, now U.S. Pat. No. 9,301,769 issued Apr. 5, 2016, which is a U.S. National Phase Application under 35 U.S.C. § 371 of International Patent Application No. PCT/IE2012/000011 filed Mar. 9, 2012, which claims benefit of provisional U.S. Patent Application No. 61/552,130 filed Oct. 27, 2011 and also claims benefit of provisional U.S. Patent Application No. 61/450,810 filed Mar. 9, 2011.
Examiner notes that subject matter in independent claims 1 and 11 is directed to Figs. 8-9 and 55 (see paragraph [00618] of the publication). However, Fig. 55 is not found in the U.S. Patent Application No. 61/450,810 filed Mar. 9, 2011.
Information Disclosure Statement
Information Disclosure Statements filed on September 17, 2024, October 28, 2024, February 12, 2025, March 17, 2025, April 16, 2025 and August 18, 2025 have been entered into the record. It is impractical for the examiner to review the references thoroughly with a large number of references cited in the Information Disclosure Statements (PTO-1449 form). By initializing each of the cited references on the accompanying 1449 forms, the examiner is merely acknowledging the submission of the cited references and indicating that only a cursory review has been made of the cited references.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 1-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ferrera et al. (US 2011/0160763, which is cited in the Information Disclosure Statement filed September 17, 2024, hereinafter “Ferrera”) in view of Rapaport et al. (US 2010/0318178, which is cited in the Information Disclosure Statement filed September 17, 2024, hereinafter “Rapaport”).
Referring to claims 1 and 11, Ferrera discloses a clot retrieval device for removing occlusive clot from a blood vessel, the device comprising: an outer elongate body comprising a collapsed delivery configuration and an expanded deployed configuration (FIGS. 33B-33C show the outer elongate body is in a collapsed delivery configuration and is inside catheter 3310. FIGS. 33D-33E show the outer elongate body is outside catheter 3310 and in an expanded deployed configuration for capturing clot 3305), wherein a diameter of the outer elongate body varies along the length of the outer elongate body (FIGS. 6A, 6B and 6D. ¶ [0262] discloses the elongate expandable body can comprise various profiles, shapes, geometries or configurations. FIG. 32F shows the elongate expandable body has a tapered shape. FIGS. 6B and 32F are reproduced below).
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Referring again to claims 1 and 11, Ferrera fails to disclose an inner elongate body comprising a collapsed delivery configuration and an expanded deployed configuration, the outer elongate body at least partially overlying (claim 1, line 5) or encircling (claim 11, line 5) the inner elongate body and wherein the outer elongate body being expandable to a radial extent which is greater than the radial extent of the inner body in the deployed configuration to define a clot reception space; and wherein a diameter of the inner elongate body varies along the length of the inner elongate body.
Referring still to claims 1 and 11, however, in the same field of endeavor, which is a clot retrieval device, Rapaport discloses the clot retrieval device includes an inner elongate body 420 located inside an outer elongate body 20 (FIG. 8, which is reproduced below). Rapaport discloses the configuration maintains perfusion while utilizing the space between the outer elongate body and the inner elongate body as a clot reception space (¶ [0095]). In light of Rapaport’s teaching, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to have provided an inner elongate body as suggested by Rapaport to the clot retrieval device of Ferrera to act as a perfusion conduit to supply oxygenated blood beyond the blockage location. FIG. 8 of Rapaport reference shows the outer elongate body and inner elongate body have similar shape to maintain a uniform clot reception space along the length of the device. Thus, it would have been obvious to make the inner elongate body to have the same tapered shape with the outer elongate body of Ferrera to maintains a uniform clot reception space.
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Referring to claims 2 and 12, Ferrera as modified by Rapaport discloses the device of claims 1 and 11, respectively, wherein a radial force profile of the device varies along the length of the device (The outer and inner expandable bodies of Ferrera device have a tapered shape, thus, the radial force profile on the device varies along the length of the device).
Referring to claims 3 and 13, Ferrera as modified by Rapaport discloses the device of claims 2 and 12, respectively, wherein the radial force at a distal end of the device is lower than that at a middle section of the device (¶ [0262] discloses the elongate expandable scaffold can comprises various profiles, shapes, geometries or configurations. FIG. 32F shows the elongate expandable scaffold has a tapered shape. It would have been obvious to shape the outer and inner expandable bodies to have a tapered shape that tapering from a large proximal end to a smaller distal end. The small distal end would have a large radial force than the middle portion and the proximal end).
Referring to claims 4 and 14, Ferrera as modified by Rapaport discloses the device of claims 1 and 11, respectively, wherein the outer elongate body comprises a diameter that tapers along the length of the device (see rejection of claims 1 and 11, paragraph 7, above).
Referring to claims 5 and 15, Ferrera as modified by Rapaport discloses the device of claims 4 and 14, respectively, wherein the outer elongate body tapers from a smaller proximal diameter to a larger distal diameter (¶ [0262] discloses the elongate expandable scaffold can comprises various profiles, shapes, geometries or configurations. FIG. 32F shows the elongate expandable scaffold has a tapered shape. It would have been obvious to shape the outer and inner expandable bodies to have a tapered shape that tapering from a smaller proximal diameter to a larger distal diameter).
Referring to claims 6 and 16, Ferrera as modified by Rapaport discloses the device of claims 4 and 14 respectively, wherein the outer elongate body tapers from a larger proximal diameter to a smaller distal diameter (¶ [0262] discloses the elongate expandable scaffold can comprises various profiles, shapes, geometries or configurations. FIG. 32F shows the elongate expandable scaffold has a tapered shape. It would have been obvious to shape the outer and inner expandable bodies to have a tapered shape that tapering from a larger proximal diameter to a smaller distal diameter).
Referring to claims 7 and 17, Ferrera as modified by Rapaport discloses the device of claims 1 and 11, respectively, wherein in the expanded deployed configuration the inner body expands to a diameter that is significantly smaller than the diameter of the vessel immediately adjacent to and distal of the occlusion (Rapaport: FIG. 8, which is reproduced above).
Referring to claims 8 and 18, Ferrera as modified by Rapaport discloses the device as claimed in claims 1 and 11, respectively, wherein the inner body comprises a generally conical shape (¶ [0262] discloses the elongate expandable scaffold can comprises various profiles, shapes, geometries or configurations, for example, tapered shape and cone-shape. FIG. 32F shows the elongate body has a tapered shape. FIG. 8 of Rapaport shows the distal end of outer elongate body has a cone-shape. Therefore, it would have been obvious to shape the outer and inner expandable bodies to have a tapered shape along the length of the body with a conical at the distal end of the body).
Referring to claims 9 and 19, Ferrera as modified by Rapaport discloses the device as claimed in claims 1 and 11, respectively, wherein the inner elongate body comprises a diameter that tapers along the length of the device (see rejection of claims 1 and 11, paragraph 7, above).
Referring to claims 10 and 20, Ferrera as modified by Rapaport discloses the device as claimed in claims 9 and 19, respectively, wherein the inner elongate body tapers from a smaller proximal diameter to a larger distal diameter (see rejection of claims 5 and 15 above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771