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 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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘evacuation lumen’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.”
Claim Objections
Claim 1 is objected to because of the following informalities: please change “outer sheath converts” to “the outer sheath is configured to convert”. Appropriate correction is required.
Double Patenting
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,303,160 in view of Ansel et al. (US 7,220,269). Claim 1 of the reference patent recites all of the limitations of claim 1 of the instant application except “retraction of the outer sheath converts the basket from the undeployed state to the deployed state.” However, Ansel et al. teaches a medical device including a basket that is deployed from within an outer sheath, wherein the sheath is capable of being withdrawn proximally or advanced distally to facilitate the removal of the device (C12:L43-45). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the outer sheath with means for retraction from about the basket, as taught by Ansel, to provide means for protection of the lumen as well as means for capturing thrombus.
Every limitation in the application under examination is recited in the conflicting reference patent claims and the differences between the claims are highlight below by bolding all limitations that differ and having explanations in parentheses. As shown in the mapping below, claim 1 of the reference patent includes all of the limitations of claim 1 of the instant application, while also reciting further limitations.
Instant Application
U.S. Patent No. 12,303,160 in view of Ansel et al. (US 7,220,269)
1. A medical device comprising: a basket configurable in a deployed state and an undeployed state; an outer sheath configured to house the basket in the undeployed state; a jet tube shaft coaxial to the outer sheath, the jet tube shaft comprising: a jet tube comprising an aperture configured to expel a fluid; a jet tube lumen sized to accept the jet tube; and an evacuation lumen; wherein retraction of the outer sheath converts the basket from the undeployed state to the deployed state.
1. A medical device comprising: a handle comprising: a distal hub; a proximal hub; and a middle hub disposed between the distal hub and the proximal hub (an obvious variant that when omitted does not affect the jet tube means used to expel a fluid); and an outer sheath coupled with the distal hub, the distal hub configured to translate movement of the distal hub to movement of the outer sheath (obvious variant that when omitted does not affect the ability of expansion of the basket); a basket configurable in a deployed state and an undeployed state; a jet tube shaft coupled with the proximal hub, the jet tube shaft coaxial to the outer sheath, the jet tube shaft comprising: a jet tube comprising an aperture configured to expel a fluid; a jet tube lumen sized to accept the jet tube; and an evacuation lumen.
4. The medical device of claim 1, the jet tube shaft further comprising a guidewire lumen sized to accept a guidewire.
The medical device of claim 1, the jet tube shaft further comprising a guidewire lumen sized to accept a guidewire.
5. The medical device of claim 4, wherein the jet tube lumen comprises a jet tube lumen cross-sectional area, the evacuation lumen comprises an evacuation lumen cross-sectional area, and the guidewire lumen comprises a guidewire lumen cross-sectional area; and wherein the evacuation lumen cross-sectional area is greater than the guidewire lumen cross-sectional area, and the guidewire lumen cross-sectional area is greater than the jet tube lumen cross-sectional area. The medical device of claim 1, the jet tube shaft further comprising a guidewire lumen sized to accept a guidewire.
The medical device of claim 3, wherein the jet tube lumen comprises a jet tube lumen cross-sectional area, the evacuation lumen comprises an evacuation lumen cross-sectional area, and the guidewire lumen comprises a guidewire lumen cross-sectional area; and wherein the evacuation lumen cross-sectional area is greater than the guidewire lumen cross-sectional area, and the guidewire lumen cross-sectional area is greater than the jet tube lumen cross-sectional area.
7. The medical device of claim 1, the jet tube further comprising a bend orthogonal to the jet tube shaft, wherein the aperture is disposed on the bend, and wherein the aperture is configured to expel fluid toward the evacuation lumen.
6. The medical device of claim 1, the jet tube further comprising a bend orthogonal to the jet tube shaft, wherein the aperture is disposed on the bend, and wherein the aperture is configured to expel fluid toward the evacuation lumen.
8. The medical device of claim 7, wherein the bend is disposed proximal to a leading edge of the basket.
7. The medical device of claim 6, wherein the bend is disposed proximal to a leading edge of the basket.
9. The medical device of claim 1, wherein the basket is composed of nitinol.
8. The medical device of claim 1, wherein the basket is composed of nitinol.
10. The medical device of claim 1, the medical device further comprising a handle, the handle comprising a ratchet coupled to one or more pull wires, wherein the one or more pull wires are coupled to a distal end of the outer sheath, and wherein actuation of the ratchet induces deflection in the distal end of the outer sheath via the one or more pull wires.
9. The medical device of claim 1, the handle further comprising a ratchet coupled to one or more pull wires, wherein the one or more pull wires are coupled to a distal end of the outer sheath, and wherein actuation of the ratchet induces deflection in the distal end of the outer sheath via the one or more pull wires.
11. The medical device of claim 10, the outer sheath further comprising one or more pull wire channels disposed in a sidewall of the outer sheath, wherein the one or more pull wire channels are sized to accept each of the one or more pull wires.
10. The medical device of claim 9, the outer sheath further comprising one or more pull wire channels disposed in a sidewall of the outer sheath, wherein the one or more pull wire channels are sized to accept each of the one or more pull wires.
12. The medical device of claim 1, wherein the basket is a mesh structure.
11. The medical device of claim 1, wherein the basket is a mesh structure.
13. The medical device of claim 1, wherein, in the undeployed state, the basket is configured to conform to the outer sheath, and wherein, in the deployed state, the basket is configured to radially expand.
12. The medical device of claim 11, wherein, in the undeployed state, the basket is configured to conform to the outer sheath, and wherein, in the deployed state, the basket is configured to radially expand.
14. The medical device of claim 13, the basket further comprising a leading edge, wherein, in the deployed state, the leading edge is concave, and wherein, in the deployed state, the basket is conical.
13. The medical device of claim 12, the basket further comprising a leading edge, wherein, in the deployed state, the leading edge is concave, and wherein, in the deployed state, the basket is conical.
15. The medical device of claim 1, the basket further comprising one or more markers, wherein the one or more markers are configured to be radiopaque in fluoroscopy and radiography.
14. The medical device of claim 1, the basket further comprising one or more markers, wherein the one or more markers are configured to be radiopaque in fluoroscopy and radiography.
16. The medical device of claim 1, the jet tube comprising a bevel disposed on a distal end of the jet tube.
15. The medical device of claim 1, the jet tube comprising a bevel disposed on a distal end of the jet tube.
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) 1-4, 6-9, 12 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ansel et al. (US 7,220,269, “Ansel”).
Regarding claims 1-3 and 6, Ansel discloses a medical device including an outer sheath (30) configured to house the basket in the undeployed state (Figs. 14-15). A basket (56; Fig. 2) is capable of having a deployed state and an undeployed state (Fig. 4,11,15). A jet tube shaft is coaxial to the outer sheath and includes a jet tube (42) including an aperture (196; Fig. 9) capable of expelling a fluid, a jet tube lumen (201; Fig. 9) sized to accept the jet tube, and an evacuation lumen (192; Fig. 10). The jet tube shaft is extendable (Fig. 14, 15). The basket is capable of preventing a vessel or surrounding tissue from entering into a path of the fluid expelled by the jet tube. A basket shaft (40; Fig. 2) is housed within the outer shaft (Fig. 15). The basket is disposed on a distal portion of the basket shaft and wherein the jet tube is positionable anywhere between a distal end of the basket and the basket shaft (Fig. 14, 15).
Regarding claim 4, Ansel discloses that the jet tube shaft includes a guidewire lumen (32; Fig. 2) sized to accept a guidewire.
Regarding claim 7, Ansel discloses that the jet tube includes a bend orthogonal to the jet tube shaft. The aperture is disposed on the bend and is capable of expelling fluid toward the evacuation lumen (Fig. 10).
Regarding claim 8, Ansel discloses that the bend is disposed proximal to a leading edge of the basket (Fig. 11, 15).
Regarding claims 9 and 12, Ansel discloses that the basket is composed of nitinol (C9;L30-47) and of a mesh structure (C4;L50-55, C12;L55-60).
Regarding claim 13, Ansel discloses that the basket is capable of conforming to the outer sheath in the undeployed state (Fig. 11) and is capable of radially expanding in the deployed state (Fig. 15).
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.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ansel in view of Leynov et al. (US 9,655,633).
Regarding claim 14, Ansel does not disclose that the basket includes a leading edge that is concave and the basket is conical in the deployed state.
In the same field of endeavor, baskets to treat thrombosis, Leynov teaches a conical basket that is formed of a mesh or braided configuration that includes a leading edge that is concave in the deployed state (Fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the leading end of the basket of Ansel with the leading end of the basket of Leynov, as this modification involves the simple substitution of one leading edge for another for the predictable result of providing blunt tip features to facilitate passage through vessels without snagging (C7;L5-20).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ansel in view of Diamant et al. (US 2010/0286709A1, Diamant).
Regarding claim 15, Ansel does not disclose that the basket includes one or more radiopaque markers capable of fluoroscopy and radiology.
In the same field of endeavor, baskets, Diamant teaches a basket that includes radiopaque markers that may be attached or placed around the filaments to increase the visualization of the basket [0071]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the basket of Ansel with one or more radiopaque markers, as taught by Diamant, to increase the visualization of the basket [0071].
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ansel in view of Stigall et al. (US 2015/0112188A1, Stigall).
Regarding claim 16, Ansel does not disclose that the jet tube may include a bevel disposed on a distal end of the jet tube but does disclose that the jet tube may have other shapes (C10;L20-28).
In the same field of endeavor, irrigation lumens, Stigall teaches a lumen used to expel fluid. The lumen has a beveled distal tip (142; [0055]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the shape of the distal end of the jet tube of Ansel with the bevel, as taught by Stigall, as this modification involves the simple substitution of one shape for another for the predictable result of providing the distal end of the jet tube with a different shape (C10;L10-28).
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hauser et al. (US 2007/0208370A1, “Hauser”) in view of Bates et al. (US 5,496,330)
Regarding claims 17-19, Hauser discloses a medical device including an outer sheath (920/820; Fig. 16A, 19; [0053, 00666]) configured to house the basket in the undeployed state [0065]. A basket (902/802; Fig. 19) is capable of having a deployed state and an undeployed state. A jet tube shaft is coaxial to the outer sheath and includes a jet tube (944) including an aperture (946;opening at distal end) capable of expelling a fluid, a jet tube lumen (812; Fig. 16) sized to accept the jet tube, and an evacuation lumen (852;lumen through which nozzle is evacuated/disposed). The jet tube shaft is extendable (Fig. 13, 14). The basket is capable of preventing a vessel or surrounding tissue from entering into a path of the fluid expelled by the jet tube (Fig. 14). The basket is capable of preventing a vessel or surrounding tissue from entering into a path of the fluid expelled by the jet tube. The basket is capable of conforming to the outer sheath in the undeployed state (Fig. 16A) and is capable of radially expanding in the deployed state (Fig. 16). However, Hauser does not disclose a slider operably coupled to the outer sheath, wherein the slider is capable of translating movement of the slider into movement of the outer sheath.
In the same field of endeavor, removal devices, Bates teaches a device including a basket (15) that may be deployed or compressed by an outer sheath (17) via a slider (14; Fig. 1; C3:L46-48, C4:L22-40) that is operably coupled to the outer sheath, wherein the slider is capable of translating movement of the slider into movement of the outer sheath. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the outer sheath of the device if Hauser with a slider, as taught by Bates, to facilitate the movement of the outer sheath to reduce the volume of the basket during delivery, to control the expansion of the basket during a procedure, and to assist in entrapping calculi within the basket after a procedure.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hauser in view of Bates, as applied to claim 19, and further in view of Leynov et al. (US 9,655,633).
Regarding claim 20, the combination of Hauser and Bates does not disclose that the basket includes a leading edge that is concave and the basket is conical in the deployed state.
In the same field of endeavor, baskets to treat thrombosis, Leynov teaches a conical basket that is formed of a mesh or braided configuration that includes a leading edge that is concave in the deployed state (Fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the leading end of the basket of the combination of Hauser and Bates with the leading end of the basket of Leynov, as this modification involves the simple substitution of one leading edge for another for the predictable result of providing blunt tip features to facilitate passage through vessels without snagging (C7;L5-20).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mitchell (US 2021/0220006A1) discloses a basket with an evacuation lumen and fluid delivery means.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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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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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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