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 .
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) 1-10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brady (US 2016/0317168 A1) in view of Diamant (US 2017/0245873 A1).
Regarding claim 1, Brady discloses:
A device for capturing material in a blood vessel (clot retrieval device 2010, see Fig. 53; see also Abstract and Para. [0888]), the device comprising:
an elongate control member (tube element(s) 2019/2021, see Fig. 53) having a proximal portion and a distal portion (see Fig. 53), the distal portion configured to be intravascularly at a treatment site in a blood vessel lumen proximate an obstruction (see Figs. 53 and 79a-79f showing the use of the device);
an expandable basket (capture basked 2011, see Figs. 53 and 79a-79f) coupled to the distal portion of the control member (see Fig. 53) with the control member extending longitudinally through the basket (see Fig. 53), the basket comprising a plurality of braided filaments defining an interior cavity (see Fig. 53);
wherein the basket has a closed distal end portion and an opening defined by a proximal edge of the basket, the opening being in communication with the interior cavity (see Fig. 53); and
first and second legs (struts 2025, see Fig. 53) having respective proximal ends coupled to the distal portion of the control member at a connection and distal ends at the proximal edge of the basket (see Fig. 53);
wherein the first and second legs are configured to position the basket within the blood vessel lumen independent of the path of the control member such that the proximal edge of the basket remains in contact with an inner surface of the blood vessel lumen when the basket is positioned around a curve (struts 2025 exert a force and provide greater lateral flexibility to the capture basket which would allow for a better seal against the vessel wall during navigation; see Para. [0888] and Fig. 53).
However, Brady is silent in regards to the material used to form struts (2025) and thus does not expressly disclose wherein each of the first and second legs are formed of bundled portions of the filaments.
In the same field of endeavor, namely clot removal devices, Diamant teaches a clot removal device (see Fig. 1B) comprising an elongate control member (140/120, see Fig. 1B); an expandable basket (filter 11, see Fig. 1B) attached to said elongate control member (see Fig. 1B) via a plurality of legs (branches 113, see Fig. 1B); wherein the legs are formed from bundled portions of filament used to form the expandable member (see Para. [0041]-[0044] and Fig. 1B).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known composition for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of forming the struts of Brady from braided filaments extending from the capture basket as disclosed by Diamant. Since Brady does not provide an express disclosure of a material of composition used to form the struts, one of ordinary skill in the art would have looked to the prior art to provide a known material/composition for forming struts connecting a clot capture basket to the elongate guide body to be used within the device of Brady. Since both the struts of Brady and Diamant are used to secure an open proximal end of a clot capture basket to the elongate guide body of the respective devices, one of ordinary skill in the art would have had a reasonable expectation of success in the resulting combination absent an express disclosure to the contrary not present in either Brady or Diamant.
Regarding claim 2, the combination of Brady and Diamant disclose the invention of claim 1, Brady, as modified by Diamant, further discloses wherein the bundled filaments of the first and second legs branch at distal ends of the first and second legs into respective upper and lower arms (see Brady Fig. 53 showing wherein each strut branches into respective lower and upper arms), wherein each of the upper arms and each of the lower arms are formed of bundled filaments (see Diamant Para. [0041]-[0044] and Fig. 1B showing wherein the branches 113 (as incorporated into the device of Brady) further branch out into additional upper sub-branches 115 at ramification point 114).
Regarding claim 3, the combination of Brady and Diamant discloses the invention of claim 2, Brady, as modified by Diamant, further discloses wherein the filaments branch distally away from the filament bundle of the respective upper and lower arms to form the sidewall of the basket (see Brady Fig. 53 showing wherein thee frame filaments branch distally away from the struts, as modified by Diamant; this is also described in Diamant Para. [0044]-[0047] how the branches (as incorporated into the device of Brady) branch distally away from their respective fiber bundles to form the sidewall of the basket).
Regarding claim 4, the combination Brady and Diamant discloses the invention of claim 3, Brady further discloses wherein: the first leg splits at its distal end into a first upper arm and a first lower arm (see Fig. 53 showing wherein each strut splits into two parallel strut portions), the first upper arm and first lower arm defining a first prong (see Fig. 53), and the second leg splits at its distal end into a second upper arm and a second lower arm, the second upper arm and second lower arm defining a second prong (see Fig. 53).
Regarding claim 5, the combination of Brady and Diamant discloses the invention of claim 4, Brady further discloses wherein the first and second upper arms converge along a circumferential direction towards one another as the first and second upper arms extend distally (see Fig. 53), and wherein the distal ends of the first and second upper arms are spaced apart from one another along a circumferential direction by a gap (see Fig. 53).
Regarding claim 6, the combination of Brady and Diamant disclose the invention of claim 5, Brady further discloses wherein the basket includes a reinforcing element (hoop 2014, see Fig. 53) extending along the first and second upper arms, with the bundled filaments, and spanning the circumferential gap between the distal ends of the first and second upper arms (see Fig. 53).
Regarding claim 7, the combination of Brady and Diamant discloses the invention of claim 4, Brady further discloses wherein the first and second lower arms converge along a circumferential direction towards one another as the first and second lower arms extend distally (see Fig. 53), and wherein the distal ends of the first and second lower arms are spaced apart from one another along a circumferential direction by a gap (see Fig. 53).
Regarding claim 8, the combination of Brady and Diamant disclose the invention of claim 7, Brady further discloses wherein the basket includes a reinforcing element (hoop 2014, see Fig. 53) extending along the first and second lower arms, with the bundled filaments, and spanning the circumferential gap between the distal ends of the first and second lower arms (see Fig. 53).
Regarding claim 9, the combination of Brady and Diamant discloses the invention of claim 4, Brady further discloses wherein the first and second prongs are diametrically opposed (see Fig. 53).
Regarding claim 10, the combination of Brady and Diamant discloses the invention of claim 4, Brady further discloses wherein a sidewall of the basket has a first region comprising the first and second prongs and a second region extending distally from the first and second prongs (see Examiner’s Diagram of Fig. 53 below illustrating a “first region” and “second region”), and wherein the sidewall is circumferentially continuous along the second region, with the exception of the openings between the interwoven filaments (see Examiner’s Diagram of Fig. 53 below).
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Examiner’s Diagram of Fig. 53
Regarding claim 13, the combination of Brady and Diamant disclose the invention of claim 1, Brady further discloses wherein the filaments do not diverge away from the bundle along the legs (see Fig. 53).
Claim(s) 11 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brady (US 2016/0317168 A1) in view of Diamant (US 2017/0245873 A1), further in view of Shrivastava (US 2020/0113588 A1).
Regarding claim 11, the combination of Brady and Diamant disclose all of the limitations of the invention of claim 10.
However, while Brady shows in Fig. 53 a decreasing pore-size in the capture basket from proximal to distal ends (due to the taper toward the distal end), Brady does not provide an express written disclosure of the shown structure and thus may not adequately disclose wherein the first and second prongs have a first average pore size and the second region has a second average pore size less than the first average pore size.
In the same field of endeavor, namely vascular clot removal devices, Shrivastava teaches a clot capture basket (see Fig. 3A) comprising a proximal structure (315, see Fig. 3A) having a first port size (see Para. [0049]-[0050]) and a distal structure (305, see Fig. 3A) having a second pore size different from the first pore size (see Para. [0049]-[0050]) to act as a secondary embolus capture device as pieces that dislodge off the embolus, that were surrounded by the capturing basket, may be trapped in the distal end of the capturing basket (see Para. [0034]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the pore sizes(s) of the capture basket of Brady to have the pores size become smaller as the basket tapers distally as taught and suggested by Shrivastava to, in this case, act as a secondary embolus capture device as pieces that dislodge off the embolus, that were surrounded by the capturing basket, may be trapped in the distal end of the capturing basket (see Shrivastava Para. [0034]).
Regarding claim 14, the combination of Brady and Diamant discloses all of the limitations of the invention of claim 1.
However, none of either Brady or Diamant expressly disclose a means of securing different portions of the capture basket to one-another and thus do not expressly disclose wherein the basket comprises a proximal structure and a distal structure coupled to the proximal structure at a circumferential joint.
In the same field of endeavor, namely vascular clot removal devices comprising an expandable basket, Shrivastava teaches wherein a clot capture basket (see Fig. 3A) comprising a proximal structure (315, see Fig. 3A) having a first port size (see Para. [0049]-[0050]) and a distal structure (305, see Fig. 3A) having a second pore size different from the first pore size (see Para. [0049]-[0050]), wherein the proximal and distal structures may be secured together by either an inter-woven braiding process or a welding process (see Para. [0050]).
Since the proximal and distal portions of the capture basket of Brady comprise differing pore sizes as the capture basket tapers distally, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the capture basket of Brady to have the different pore-size sections of the capture basket secured together by a welding process as taught and suggested by Shrivastava whom provides known method within the art of securing these features. Since a weld would need to be circumferential to ensure securement, the resulting securement weld would constitute a circumferential joint.
Regarding claim 15, the combination of Brady, Diamant and Shrivastava disclose the invention of claim 14.
While Brady shows wherein the proximal and distal portions of the capture basket comprise tapering pore sizes as the capture basket tapers distally, Brady does not expressly disclose wherein the proximal and distal sections are formed from different filaments and thus does not expressly disclose wherein the filaments are first filaments and the proximal structure is formed of the first filaments, and the distal structure is formed of a plurality of interwoven second filaments.
Shrivastava further teaches wherein the capture basket (see Fig. 3A) comprises a proximal section with larger pores (see Para. [0031] and [0049]) and a distal portion with smaller pores (see Para. [0031] and [0049]); wherein the different sections of different pore sizes are formed from different braided wires connected together to form the varying pore sizes across the device (see Para. [0031]m [0034] and [0049]-[0050]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have formed the varying pore gradient along the length of the capture basket of Brady by forming each section from different braided fibers as taught by Shrivastava. Since Brady does not provide an express disclosure of how the capture basket is formed so as to have tapering, decreasing pore sizes toward the distal end of the device, one of ordinary skill in the art would have looked to the prior art, such as the disclosure of Shrivastava, for known methods of achieving such a construction. Since the resulting combination incorporates a known method of producing the pore size gradient shown in Brady Fig. 53, one of ordinary skill in the art would have had a reasonable expectation of success in the resulting combination.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brady (US 2016/0317168 A1) in view of Diamant (US 2017/0245873 A1), further in view of Dubrui (US 2014/0188127 A1).
Regarding claim 12, the combination of Brady and Diamant disclose all of the limitations of the invention of claim 10.
However, none of either Brady of Diamant expressly disclose a PIC count for different portions of the capture basket(s) and thus do not expressly disclose wherein the first and second prongs have a first pic count and the second region has a second pic count greater than the first pic count (see Fig. 53).
In the same field of endeavor, namely vascular occlusion treatment devices, Dubrui teaches wherein an expandable capture basket (see Fig. 49) may comprise a distal portion (280, see Fig. 49) having a higher PIC count and a proximal portion (282, see Fig. 49) having a lower PIC count to allow the distal portion to buckle first as long as it can fully expand in the vessel; the higher the PIC count, the less the section will expand under axial compression, thereby limiting expansion of the capture basket to a desired amount (see Para. [0140]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the PIC count of the capture basket of Brady to comprise a higher PIC count in the second region as taught and suggested by Dubrui to, in this case, allow the distal portion of the capture basket to buckle first under compression (see Dubrui Para. [0140]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s
disclosure. See the attached PTO-892 Notice of Reference Cited. Specifically, US 2011/0125181 A1, US 2004/0116960 A1, US 8591540 B2, US 8480702 B2, US 7850708 B2, US 7331973 B2, US 8182508 B2, US 9089404 B2 and US 8152831 B2 all disclose vascular clot removal devices comprising an expandable scaffold element having an open proximal end secured to a guide shaft with one or more struts.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771