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 .
Benefit
The application filed 10/8/2024 is a Continuation of 18/058955 (11/07/2022), issued as US 12,156,671 (12/03/2024), which claims benefit as a Continuation to 16/717,345 (12/17/2019), issued as US 11,510,691 (11/29/2022), which claims benefit as a Continuation to 16/207,768 (12/3/2018), issued as US 10,512,479 (12/24/2019), which claims benefit as a Continuation to 15/845,086 (12/18/2017), issued s 10,143,482 (12/04/2018), which claims benefit as a Continuation to 15/581,272 (4/28/2017), issued as US 9,844,386 (12/19/2017), which claims benefit as a Continuation to 15/376,448 (12/12/2016), issued as US 9,636,206 (05/02/2017), which claims benefit as a Continuation to 15/230,109 (08/05/2016), issued as US 9,579,116 (02/28/2017), which claims benefit to US Provisional 62/345,863 (6/6/2016), US Provisional 62/273,418 (12/30/2015), and US Provisional 62/202,074 (08/06/2015).
Formal Matters
Claims 1-20 are pending and under examination.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Obviousness-Type Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 16, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, and 19 of U.S. Patent 12,156,671 (3 December 2024) in view of Cully et al., US 20140046358 (13 February 2014). This is not a provisional rejection.
Independent claims 1, 16, and 20 of instant ‘143 application are obvious over claims 1, 15, and 19 of the ‘671 patent (same assignee/inventive entity) in view of Cully. A claim comparison chart is provided below for ease of reference.
The claims of the ‘671 patent do not expressly recite that the body everts at the fold point, using that express textual language. However, both claims 1 and 19 of the ‘671 patent recite: “wherein the body is configured to transform from the first configuration to the second configuration in response to maintaining the second shaft in a constant position while the first shaft moves proximally with respect to the distal tip.”
Cully teaches that eversion may occur at a fold (¶41) and eversion (or to evert) is defined as the act, condition, or ability of being turned inside out or vice versa (¶35). Cully teaches that this occurs where a first frame extends away from a second frame in a non-everted or un-everted condition, where the first frame element can be everted into the second frame element (¶35). Claim 1 of Cully discloses that “a distal filter net is configured to evert into the proximal filter net upon deployment in a host vessel wherein the central frame is configured to have minimum contact points with the host vessel and comprises a hinged portion (e.g. fold) configured to allow the distal end of the central frame to evert with respect to the proximal end of the central frame” (claim 1). This is the same action as the last wherein-clause of the ‘671 patent “and wherein the body is configured to transform from the first configuration to the second configuration in response to maintaining the second shaft in a constant position while the first shaft moves proximally with respect to the distal tip”. The teachings of Cully provide evidence of the requirements of and function of everting (turning inside out) “when a body is configured to transform from a first configuration to a second configuration in response to maintaining the second shaft in a constant position while the first shaft moves proximally with respect to the distal tip” (from claims 1 and 20 of the ‘671 patent, the last wherein clause).
Additionally, claims 1 and 19 of the ‘671 patent refer to a body comprising a first and a second end. Claims 1 and 20 of the ‘143 application recite that the body comprises a fold point where the body everts (turns inside out) and also comprises a proximal-facing opening, necessarily suggesting that the body has proximal and distal ends.
US 12,156,671
18/909,143
1. A material capture system comprising: a first shaft defining a central lumen; a second shaft comprising a distal tip, the second shaft configured to be positioned within the central lumen of the first shaft; and a body comprising a first end, a second end, and
a fold point between the first and second ends, wherein the first end defines a
proximal-facing opening and is attached to the first shaft, and wherein the second end is attached to the second shaft, wherein the body is configured to be transformed between a first configuration in which the first end is expanded and a first axial distance separates the fold point and the distal tip and a second configuration in which the first end is expanded and a second axial distance separates the fold point and the distal tip, the second axial distance being different than the first axial distance: and wherein the body is configured to transform from the first configuration to the second configuration in response to maintaining the second shaft in a constant position while the first shaft moves proximally with respect to the distal tip.
A material capture system
comprising: a first shaft defining a central lumen; a second shaft comprising a distal tip, the second shaft configured to be positioned within the central lumen of the first shaft; and a body attached to the first shaft and the second shaft, the body defining:
a fold point where the body everts;
and a proximal-facing opening configured to receive a thrombus,
wherein the body is configured to be transformed between: a first configuration in which the proximal-facing opening is expanded and a first axial distance separates the fold point and the distal tip, and a second configuration in which the proximal-facing opening is expanded and a second axial distance separates the fold point and the distal tip, the second axial distance being different than the first axial distance.
15. A material capture system comprising: a first shaft defining a central lumen; a second shaft comprising a distal tip, the second shaft configured to be positioned within the
central lumen of the first shaft; and a body comprising a first end, a second end, and a dynamic fold point between the first and second ends, wherein the first end defines a proximal-facing opening and is attached to the first shaft, and wherein the second end is attached to the second shaft proximal the distal tip, wherein the body is configured to be transformed between a first configuration in which the first end is expanded and a first axial distance separates the dynamic fold point and the distal tip and a second configuration in which the first end is expanded and a second axial distance separates the dynamic fold point and the distal tip, the second axial distance being greater than the first axial distance, wherein in the first configuration, a first expanded axial length of the body separates the dynamic fold point and the proximal-facing opening of the body, and wherein in the second configuration, a second expanded axial length of the body separates the dynamic fold point and the proximal-facing opening of the body, the second expanded axial length being greater than the first expanded axial length.
16. A material capture system comprising: a first shaft defining a central lumen; a second shaft comprising a distal tip,
the second shaft configured to be positioned within the
central lumen of the first shaft; and a body attached to the first shaft and the second shaft, the body defining: a fold point where the body everts; a proximal-facing opening at a first end of the body, the proximal-facing opening configured to receive a thrombus; and a second shaft attachment point spaced apart from the first end, wherein the body is attached to the second shaft at the second shaft attachment point, and wherein the body is configured to be transformed between: a first configuration in which the proximal-facing opening is expanded and a first axial distance separates the fold point and the distal tip, and a second configuration in which the proximal-facing opening is expanded and a second axial distance separates the fold point and the distal tip, the second axial distance being different than the first axial distance, and wherein in the first configuration and the second configuration, the distal tip of the second shaft is distal to the fold point.
19. A method comprising: positioning a material capture system near an obstruction, the material capture system comprising: a first shaft defining a central lumen; a second shaft comprising a distal tip, the second shaft configured to be positioned within the central lumen of the first shaft; and a body
comprising a first end, a second end, and a fold point between the first and second ends, wherein the first end defines a proximal-facing opening and is attached to the first shaft, and wherein the second end is attached to the second shaft;
and transforming the material capture system
between a first configuration in which the first end is expanded and a first axial distance separates the fold point and the distal tip and a second configuration in which the first end is expanded
and a second axial distance separates the fold point and the distal tip, the second axial distance being different than the first axial distance: wherein the body is configured to transform from the first configuration to the second configuration in response to maintaining the second shaft in a constant position while the first shaft moves proximally with respect to the distal tip.
20. A method comprising: positioning a material capture system near an
obstruction, the material capture
system comprising: a first shaft
defining a central lumen, a second shaft comprising a distal tip, the
second shaft configured to be
positioned within the central lumen of the first shaft, and a body
attached to the first shaft and the second shaft, the body defining:
a fold point where the body everts, and a proximal-facing opening configured to receive a thrombus;
and transforming the material capture
system, for capturing the obstruction, between: a first configuration in which the proximal-facing opening is expanded and a first axial distance separates the fold point and the distal tip, and a second configuration in which the proximal-facing opening is expanded
and a second axial distance separates the
fold point and the distal tip, the second axial distance being different than the first axial distance.
Allowable Subject Matter
Claims 2-15 and 17-19 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.
Lund-Clausen et al., US 20150005781 (1 January 2015) is the closest prior art. Lund-Clausen teaches a first configuration in which the first end of the basket is located within the distal end of the catheter and the second end of the basket extends radially out of the catheter and is everted over the first end of the basket and a second configuration in which the first end of the basket is withdrawn into the catheter and the everted second end is at least partially inverted. However, the body of the Lund-Clausen device is not attached to the first shaft and the second shaft. Burns et al., US 6,569,181 (27 May 2003) is also relevant prior art. Burns teaches the body attached to the first shaft and the second shaft, but no axial distance or fold point is taught. However, the designs of the devices of Burns and Lund-Clausen are not compatible as a combination without significant underlying modifications requiring more than ordinary experimentation.
Conclusion
Claims 1, 16, and 20 are rejected. Claims 2-15 and 17-19 are objected to.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lund-Clausen et al., US 9,427,244 (30 August 2016) teaches object capture devices (issued version of Lund-Clausen et al., US 20150005781 (1 January 2015) cited above).
Jensen et al., US 9,814,477 (14 November 2017) teaches clot retrieval systems with inverted sleeve.
Cooper et al., US 20150265299 (24 September 2015) teaches minimally invasive thrombectomy.
Martin et al., US 9,254,371 (9 February 2016) teaches retrieval systems and methods for use thereof.
Martin et al., US 8,795,305 (5 August 2014) teaches retrieval systems and methods for use thereof.
Hopkins et al., US 20130238009 (12 September 2013) teaches vascular device for emboli, thrombus, and foreign body removal and methods of use.
Strauss, US 20130102996 (25 April 2013) teaches system for removing thrombus.
Dubrul et al., US 6,221,006 (24 April 2001) teaches entrapping apparatus and methods of use.
Cully et al., US 9,308,007 (12 April 2016) teaches devices and systems for thrombus treatment.
Freundenthal et al., US 20060155305 (13 July 2006) teaches extraction devices.
Sepetka et al., US 6,663,650 (16 December 2003) teaches systems, methods, and devices for removing obstructions from a blood vessel.
Frimerman, US 20120330346 (27 December 2012) teaches endoluminal catheterization device for use in treatment of coronary artery disease in atherosclerosis patients.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771