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 .
Priority
This application is a CON of 17/986,700 11/14/2022 PAT 12059165
17/986,700 is a CON of 16/790,744 02/14/2020 PAT 11497514
16/790,744 is a CON of 15/795,097 10/26/2017 PAT 10561431
15/795,097 is a DIV of 15/496,668 04/25/2017 PAT 9962178
15/496,668 has PRO 62/357,677 07/01/2016
15/496,668 has PRO 62/345,152 06/03/2016
15/496,668 has PRO 62/327,024 04/25/2016 is acknowledged.
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 2, 7-8 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 2 recites “a distal end of the inversion support catheter”. This limitation is already recited in claim 1. It is unclear if this is a new limitation or the same as in claim 1.
Claim 7 recites the limitation "the support catheter" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites “a distal end of the inversion support catheter”. This limitation is already recited in claim 1. It is unclear if this is a new limitation or the same as in claim 1.
Applicant is advised that should claim 15 be found allowable, claim 18 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m)
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, 13, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0005781 Lund-Clausen et al. (Lund-Clausen).
Lund-Clausen teaches:
Claim 1: An apparatus for removing a clot from a vessel, the apparatus comprising:
an outer catheter (10, Fig. 1) defining a lumen and including an open distal end (10d, Fig. 1);
an inversion support catheter (12, Fig. 1) pre-loaded within the lumen of the outer catheter, the inversion support catheter having a proximal end and a distal end, the distal end defining a distal end opening (12d, Fig. 1), wherein the inversion support catheter includes a length such that the distal end of the inversion support catheter is configured to be extendable distally beyond the open distal end of the outer catheter (functional limitation, the catheter 12 is capable of doing such);
a tractor (basket 14, Fig. 1) comprising a flexible tube (para. 0013) that extends within the inversion support catheter (Fig. 1), inverts over the distal end opening of the inversion support catheter, and extends over an outer surface of the inversion support catheter, wherein the tractor is configured to invert by rolling over the distal end opening of the inversion support catheter when a first end of the tractor (16, Fig. 1) is pulled proximally within the inversion support catheter (Fig. 1); and
a puller (20, Fig. 1) having a distal end coupled to the first end of the tractor (16, Fig. 1), wherein the puller extends proximally within the inversion support catheter.
Claim 13: An apparatus for removing a clot from a vessel, the apparatus comprising:
an outer catheter (10, Fig. 1) defining a lumen and including an open distal end;
an inversion support catheter (12, Fig. 1) pre-loaded within the lumen of the outer catheter, the inversion support catheter having a proximal end and a distal end, the distal end defining a distal end opening, wherein the inversion support catheter includes a length such that in a first position, the distal end of the inversion support catheter is disposed within the lumen of the outer catheter, and in a second position, the distal end of the inversion support catheter extends distally beyond the open distal end of the outer catheter (functional limitation, the catheter 12 is capable of doing such);
a tractor (14, Fig. 1) comprising a flexible tube that extends within the inversion support catheter, inverts over the distal end opening of the inversion support catheter, and extends over an outer surface of the inversion support catheter, wherein the tractor is configured to invert by rolling over the distal end opening of the inversion support catheter when a first end of the tractor (16, Fig. 1) is pulled proximally within the inversion support catheter; and
a puller (20, Fig. 1) having a distal end coupled to the first end of the tractor, wherein the puller extends proximally within the inversion support catheter.
Claim 19: A method of removing a clot from a vessel, the method comprising:
positioning a distal portion of an apparatus (Fig. 1) adjacent to the clot within the vessel (Fig. 1), the apparatus including;
an outer catheter (10, Fig. 1) defining a lumen (where 12 is within) and including an open distal end (10d, Fig. 1);
an inversion support catheter (12, Fig. 1) pre-loaded within the lumen of the outer catheter, the inversion support catheter having a proximal end and a distal end, the distal end defining a distal end opening (12d, Fig. 1), wherein the inversion support catheter includes a length such that the distal end of the inversion support catheter is configured to be extendable distally beyond the open distal end of the outer catheter (functional limitation, the catheter 12 is capable of doing such);
a tractor (14, Fig. 1) comprising a flexible tube that extends within the inversion support catheter, inverts over the distal end opening of the inversion support catheter, and extends over an outer surface of the inversion support catheter (Fig. 1); and
a puller (20, Fig. 1) having a distal end coupled to the first end (16, Fig. 1) of the tractor, wherein the puller extends proximally within the inversion support catheter;
extending the distal end of the inversion support catheter distally beyond the open distal end of the outer catheter (Fig. 2);
pulling the puller proximally to roll the tractor over the distal end of the inversion support catheter so as to draw the clot into the inversion support catheter with the tractor (Fig. 3).
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.
Claim(s) 2, 10-11, 14 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lund-Clausen in view of US 2009/0192485 to Heuser.
Lund-Clausen teaches:
The apparatus of claim 1 (see rejection of claim 1 above).
Lund-Clausen fails to teach:
Claims 2 and 14: A distal end of the inversion support catheter is configured to expand such that the distal end opening is expandable from a first smaller size to a second larger size.
Claims 10 and 16: The distal end of the inversion support catheter is expandable to assume a funnel shape.
Claims 11 and 17: The distal end of the inversion support catheter is expandable such that the distal end opening is configured to flared out from a smaller size to a larger size.
Heuser teaches:
Claims 2 and 14: In the same field as endeavor, a device for removing clot and thrombi having an expandable catheter (20, Fig. 2) having expandable distal end (22, Fig. 2) for receiving the clot or thrombi (para. 0011) such that the opening is expandable from a first smaller size to a larger size (Figs. 4A-B).
Claims 10 and 16: The distal end of the inversion support catheter (22, Fig. 2) is expandable to assume a funnel shape.
Claims 11 and 17: The distal end of the inversion support catheter (22, Fig. 2) is expandable such that the distal end opening is configured to flared out from a smaller size to a larger size (Figs. 4A-B).
It would have been obvious for one of ordinary skill in the art at the time of the invention was filed to modify the distal end of the inversion catheter (12 in Lund-Clausen) to be expandable for receiving a larger clot or thrombi.
Claim(s) 12, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lund-Clausen in view of US 11,529,158 to Hauser.
Lund-Clausen teaches:
The apparatus of claim 1 (see rejection of claim 1 above).
Lund-Clausen fail to teach:
Claim 12: The outer catheter is adapted as a vacuum clot removal catheter.
Claim 20: applying aspiration through the outer catheter.
Hauser teaches:
In the same field as endeavor, a method for treating vascular occlusion, comprises an outer catheter (920, Fig. 15) adapted as a vacuum clot removal catheter (catheter 920 is an aspiration catheter and therefore is adapted as a vacuum for clot removal).
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to modify the outer catheter to be adapted as a vacuum clot removal catheter as taught by Hauser in order to enhance removal of clot in the body.
Allowable Subject Matter
Claims 3-9, 15, 18 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, the prior art fails to disclose the distal end of the inversion support catheter is configured to expand such that the distal opening assumes a larger size when the puller is pulled proximally to roll the tractor over the distal end opening.
Regarding claim 4, the prior art fails to disclose a sleeve disposed on the distal end of the inversion support catheter, where the sleeve is expandable.
Regarding claim 5, the prior art fails to disclose the distal end of the inversion support catheter comprises a plurality of longitudinal strands extending in a proximal-to-distal direction and the strands configured to separate to cause the distal opening to enlarge. Claim 6 also objected for depending on objected claim 5.
Regarding claim 7, the prior art fails to disclose the inversion support catheter includes longitudinal slots defined in the distal end portion of the inversion support catheter. Claim 8 also objected for depending on objected claim 7.
Regarding claims 9, 15 and 18, the prior art fails to disclose the distal end of the inversion support catheter is configured to be elastically deformable in a radial direction while resist deformation along a proximal-to-distal axis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHONG SON DANG whose telephone number is (571)270-5809. The examiner can normally be reached Mon-Fri 8-5.
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/PHONG SON H DANG/Primary Examiner, Art Unit 3771