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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: reference number 2218 in [0237].
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 actuatable frame mechanically coupled to the at least one mechanical engagement feature, the actuatable frame having at least a portion positioned proximally from the funnel frame (claim 11) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. As presently seen in Figs. 14A and 14B, the actuatable frame (26) that is located proximally from the funnel frame comprises or is made up of the mechanical engagement features (22a). The actuatable frame is not an element separate from the mechanical engagement features as claimed.
The drawings are objected to because of the gray shading used to indicate the inventive features in Figs. 6A-6E, 13A-13B, 14A-14B, 17A-17B, 18A-18F, 19A-19D, 20A-20C. The drawings must be of sufficient quality such that all details in the drawings are reproducible in black and white in a printed patent (MPEP 608.02 and 37 CFR 1.84). The gray shading renders the images unclear and may affect the quality of images if and when the images are reproduced for printing in a patent.
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. 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 § 102
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 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) 1-5, 9-11, 19 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamanouchi (US 2019/0008550).
Yamanouchi discloses the following limitations:
Claim 1. A thrombus removal device (Figs. 1-4), comprising:
an elongate catheter (23) having an aspiration lumen (24) ([0055]);
an aspiration source (syringe) coupled to the aspiration lumen ([0055], [0080]);
an expandable funnel (12) coupled to the aspiration lumen and the elongate catheter ([0056]);
at least one mechanical engagement feature (44) disposed within the expandable funnel, wherein the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement feature within the expandable funnel ([0064]-[0067], [0079]).
Claim 2. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement within the expandable funnel towards the aspiration lumen ([0067]; from Fig. 4 to Fig. 2, blades 44 collapse radially inward towards the aspiration lumen).
Claim 3. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement feature generally radially within the expandable funnel across at least a portion of the expandable funnel ([0067]; between Fig. 2 and Fig. 4, blades 44 collapse radially inward or expands radially outward within the expandable funnel).
Claim 4. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature comprises a cutting portion (44) ([0065]-[0067]).
Claim 5. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature comprises a blunted tip (blade 44 terminates in a non-pointed end 44b as seen in Figs. 2-4 and is thus considered blunted).
Claim 9. The thrombus removal device of claim 1, wherein the expandable funnel comprises a funnel frame (31) configured to self-expand the funnel to a fully expanded configuration (Fig. 4; [0057], [0058]).
Claim 10. The thrombus removal device of claim 9, wherein the expandable funnel further comprises a compliant material (32) disposed over at least a portion of the funnel frame (Figs. 2-4; [0060]).
Claim 11. The thrombus removal device of claim 9, further comprising an actuatable frame (41) (can be actuated axially) mechanically coupled to the at least one mechanical engagement feature (44), the actuatable frame having at least a portion positioned proximally from the funnel frame (31) (Fig. 2; [0064])
Claim 19. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature includes a pair of mechanical engagement features (44) configured to create a shearing action when actuated ([0064], rotation of third tube 41 causes rotation of blades 44, the rotational movement of the blades are configured to cause a shearing force against the captured thrombus and thereby encompasses the claimed language of ‘shearing action’).
Claim 20. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature comprises a plurality of mechanical engagement features (44) that are collectively actuated as a group ([0064]-[0067]).
Claim(s) 1-9 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berrada et al (WO 2021/178696).
Berrada et al discloses the following limitations:
Claim 1. A thrombus removal device (100) (Figs. 1A-1E), comprising:
an elongate catheter (102) having an aspiration lumen (106) ([0040]);
an aspiration source (140; e.g. vacuum pump) coupled to the aspiration lumen ([0040]; Fig. 1B);
an expandable funnel (109) coupled to the aspiration lumen and the elongate catheter (Figs. 1C-1E; [0027]-[0031]);
at least one mechanical engagement feature (110) disposed within the expandable funnel, wherein the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement feature within the expandable funnel ([0030]-[0035]).
Claim 2. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature (110) is actuatable to move the at least one mechanical engagement within the expandable funnel towards the aspiration lumen (Fig. 1D; [0030], the mechanical engagement feature can be moved proximally in the direction of D2 towards the aspiration lumen 106).
Claim 3. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature (110) is actuatable to move the at least one mechanical engagement feature generally radially within the expandable funnel across at least a portion of the expandable funnel (Fig. 1D; [0030], the mechanical engagement feature rotates radially in the direction of D1 within the expandable funnel).
Claim 4. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature comprises a cutting portion (110) ([0030]; i.e. the screw penetrates into thrombus and is therefore considered a cutting portion).
Claim 5. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature comprises a blunted tip (at element 113 in Figs. 1C-1E).
Claim 6. The thrombus removal device of claim 1, further comprising:
a fluid source (144) (Fig. 1B; [0046]);
a fluid lumen (lumen of tube 128as) positioned in the elongate catheter and in fluid communication with the fluid source (Fig. 1E; [0037]);
a jet orifice (129a) positioned near or within the expandable funnel and in fluid communication with the fluid lumen, the jet orifice being configured to provide a fluid stream (126a) within the aspiration lumen or within the expandable funnel (Fig. 1E; [0037]).
Claim 7. The thrombus removal device of claim 6, wherein the at least one mechanical engagement feature (110) is actuatable to move the at least one mechanical engagement within the expandable funnel towards the fluid stream (Fig. 1D; [0030], the mechanical engagement feature can be moved proximally in the direction of the fluid stream).
Claim 8. The thrombus removal device of claim 6, wherein at least one mechanical engagement feature (110) is in fluid communication with the fluid lumen (Fig. 1E) and is further configured to provide a second fluid stream (126b) within the aspiration lumen or within the expandable funnel ([0037]).
Claim 9. The thrombus removal device of claim 1, wherein the expandable funnel (109) comprises a funnel frame configured to self-expand the funnel to a fully expanded configuration ([0027]).
Claim 20. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature comprises a plurality of mechanical engagement features (each thread of screw 110 is considered a mechanical engagement feature, and therefore there are a plurality of threads as seen in Figs. 1C-1E) that are collectively actuated as a group (collectively rotated; [0031]).
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) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamanouchi in view of McKenzie et al (US 5993469).
Claim 18. Yamanouchi discloses the invention substantially as claimed above, including the at least one mechanical engagement feature includes a pair of mechanical engagement features (44) but fails to disclose the pair of mechanical engagement features is configured to collide at a pinch point when actuated.
However, in a similar field of endeavor of removing unwanted materials from the blood vessel, McKenzie et al teaches a removal device comprising a pair of mechanical engagement features (240) configured to collide at a pinch point when actuated (Figs. 11A, 11B; col. 17, ll. 20-48). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the pair of mechanical engagement features of Yamanouchi such that they are configured to collide at a pinch point when actuated to provide an additional grasping force (as opposed to just vacuum force) to remove the thrombus.
Allowable Subject Matter
Claims 12-17 are 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 and if the drawing objection to claim 12 can be obviated without adding new matter.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Yamanouchi, discloses the invention substantially as claimed above.
In regards to claim 12, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed thrombus removal device comprising, inter alia, a sheath configured to slide axially over the elongate catheter, wherein relative movement therebetween to place the sheath into contact with the actuatable frame moves the at least one mechanical engagement feature within the expandable funnel. The sheath (21) of Yamanouchi is not configured to slide and make contact as claimed to move the at least one mechanical engagement feature.
In regards to claim 14, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed thrombus removal device comprising, inter alia, wherein the at least one mechanical engagement feature is coupled to the funnel frame at a hinge. Instead, the mechanical engagement feature (44) is coupled to another tube (41) at a proximal hinge.
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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.
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
Prosecution Insights