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.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“controllable steering mechanism” configured to orient said operational distal end [0093, 0134, 0140, 0150, 0236] in claims 2 and 43. In [0134] the controllable steering mechanism includes at least one wire that runs from the handle to the operational distal end, wherein the at least one wire runs inside a counter sleeve on the elongated body which would assist in manipulating the distal end.
“automatic lead tensioning mechanism” configured to automatically pull the lead, thereby allowing a single operator to operate said system [0149, 0235, 0651, 0658] in claim 43.In [0658] the lead tensioning mechanism (150) includes a body (152), gripping teeth (154) and a motor (not shown) adapted to move the gripping teeth.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim(s) 20 and 34 is/are objected to because of the following informalities: Please change “said lead extraction assistive tool” to “said at least one lead extraction assistive tool”. Appropriate correction is required.
Claim(s) 20 is/are objected to because of the following informalities: Please change “said transmission” to “said at least one transmission”. Appropriate correction is required.
Claim(s) 54 is/are objected to because of the following informalities: Please change “an trigger” to “a trigger”. Appropriate correction is required.
Claim(s) 54 is/are objected to because of the following informalities: Please change “trigger which selectively releases” to “trigger configured to selectively release”. Appropriate correction is required.
Claim(s) 55 is/are objected to because of the following informalities: Please change “axial force is applied directly” to “axial force is configured to be applied directly”. Appropriate correction is required.
Claim(s) 55 is/are objected to because of the following informalities: Please change “axial force is applied indirectly” to “axial force is configured to be applied indirectly”. Appropriate correction is required.
Claim(s) 55 is/are objected to because of the following informalities: Please change “said local energy store is charged” to “said local energy store is configured to be charged”. Appropriate correction is required.
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.
Claim(s) 20, 43, 54 and 55 is/are 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 20 recites the limitation "said motor" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 43 is indefinite because one of ordinary skill in the art cannot determine the metes and bounds of the claim scope. The scope of the claim is ambiguous and cannot be ascertained since the claim requires part “d” and the limitation of part “i” states, “instead of d”. Reciting part “d” and then substituting/removing “d”, as recited in part “i” makes the scope of the claim unclear. For the purpose of art rejection, the claim will be interpreted as the system including “d” or “i” as the operational distal end/accessary and understood to be used as an alternative. Please amend to remove “instead of d” or convert to an unambiguous alternative format (e.g., “wherein the system includes one of d or i”). The current wording fails to particularly point out and distinctly claim the metes and bounds of the claim scope, if an operational distal end is required or not.
Claim 54 recites the limitation "said energy" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 55 recites the limitation "the apparatus" in lines 3 and 9. There is insufficient antecedent basis for this limitation in the claim.
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(s) 1, 2, 3, 4, 6, 11, 12, 17, 18, 20, 33, 34, 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 2, (4,7, 8, 9, 10), 5, 6, 11, (13, 14, 15), 16, 18, (22, 23, 24, 25, 26, 27, 28, 29, 30, 31), 32, 33, 12 of U.S. Patent No. 12,318,116. The applications are commonly owned. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 1, 2, 3, 4, 6, 11, 12, 17, 18, 20, 33, 34, 43 under examination are anticipated by claim(s) 1, 2, (4,7, 8, 9, 10), 5, 6, 11, (13, 14, 15), 16, 18, (22, 23, 24, 25, 26, 27, 28, 29, 30, 31), 32, 33, 12 of the reference application U.S. Patent No. 12,318,116 the patent claims.
Instant Application 18/292350
Corresponding Claims of reference US Patent 12,318,116 (bolded terms are differences between instant and reference claims)
Claims 1 and 5) A cardiac lead extraction system, comprising: a. a handle; b. an elongated body in communication with said handle; c. a bendable flexible portion in communication with said elongated body, said bendable flexible portion comprising a first lumen sized and shaped to fit over a cardiac lead; said bendable flexible portion being more flexible than said elongated body; d. an operational distal end in communication with said bendable flexible portion; wherein said bendable portion is configured to bend to a bending radius of less than 4cm while keeping said first lumen open; and wherein said operational distal end comprises at least one lead extraction assistive tool, said operational distal end comprising a second lumen sized and shaped to fit over a cardiac lead, said second lumen being in communication with said first lumen, and said first lumen comprises an inner diameter of from about 1mm to about 8mm.
Claim 1) A cardiac lead extraction system, comprising: a. a handle; b. an elongated body in communication with said handle; c. an external bendable flexible portion in communication with said elongated body, said external bendable flexible portion comprising a first lumen sized and shaped to fit over a cardiac lead; said external bendable flexible portion being more flexible than said elongated body; d. an operational distal end in communication with said external bendable flexible portion; wherein said external bendable flexible portion is configured to bend to a bending radius of less than 4cm while keeping said first lumen open; and wherein said operational distal end comprises at least one lead extraction assistive tool, said operational distal end comprising a second lumen sized and shaped to fit over said cardiac lead, said second lumen being in communication with said first lumen, and said first lumen comprises an inner diameter of from about 1mm to about 5mm; wherein said system comprises a pedal in communication with said handle, said pedal configured for activating said operational distal end; wherein said operational distal end comprises at least one impact mechanism positioned within said operational distal end, said at least one impact mechanism comprising at least one spring and at least one movable component; said spring configured to provide momentum to said at least one component which performs an impact action once said spring is released.
Claims 2 and 43) A cardiac lead extraction system configured to be operated by a single operator, comprising: a. a handle; b. an elongated body in communication with said handle; c. a bendable flexible portion in communication with said elongated body, said bendable portion being more flexible that said elongated body; d. an operational distal end in communication with said bendable flexible portion, said operational distal end comprises at least one lead extraction assistive tool; wherein said system comprises at least one selected from the group consisting of: e. an automatic lead tensioning mechanism configured to automatically pull said lead, thereby allowing a single operator to operate said system; f. a controllable steering mechanism configured to orient said operational distal end; g. a motor; h. a lead cutter assistive component; i. an operational distal end accessory, instead of said operational distal end, said operational distal end accessory comprising: I. a body configured to be mounted on a distal end of said elongated body; II. said at least one lead extraction assistive tool; and III. a hand controller configured to control said at least one lead extraction assistive tool
Claim 2)
The system of claim 1, wherein said system further comprises a controllable steering mechanism configured to orient said operational distal end.
Claim 43 requires the system of claim 1 and at least one selected from the group which includes a controllable steering mechanism configured to orient said operational distal end as disclosed in claim 2.
Claim 3
The system of claim 1, wherein said bendable portion is configured to perform one or more of the following: a. bend to a minimum bending radius of from about 2mm to about 15mm;b. bend to a maximal angle of from about 35 degrees to about 150 degrees; c. change in length from about 0% to about 10% during said maximal angle; d. perform a movement from 0 degrees to about 180 degrees; e. bend to said maximal angle during active deflection of the system while withstanding forces up to 3000gf; and f. bend to said maximal angle during passive deflection of the system while withstanding forces up to 500gf.
Claims 4, 7, 8, 9, 10
4. The system of claim 1, wherein said external bendable flexible portion is configured to bend to a minimum bending radius of from about 2 mm to about 15 mm.
7. The system of claim 1, wherein said external bendable flexible portion bends to a maximal angle of from about 35 degrees to about 150 degrees.
8. The system of claim 7, wherein an inner diameter of said external bendable flexible portion changes in length from about 0% to about 10% during said maximal angle.
9. The system of claim 7, wherein one or more of the following is true: a. said external bendable flexible portion is capable of bending to said maximal angle during active deflection of the system while withstanding forces up to 3000 gf; b. said external bendable flexible portion is capable of bending to said maximal angle during passive deflection of the system while withstanding forces up to 500 gf.
10. The system of claim 1, wherein said external bendable flexible portion is configured to perform a movement from 0 degrees to about 180 degrees.
The reference claims disclose at least one or more of a through f which meets the claimed limitations.
Claim 4
The system of claim 1, wherein said bendable portion comprises at least one articulated structure configured to maintain said first lumen open.
Claim 5
The system of claim 1, wherein said external bendable flexible portion comprises at least one articulated structure configured to maintain said first lumen open.
Claim 6
The system of claim 1, wherein the outer diameter of said cardiac lead extraction system is from about 5mm to about 8mm.
Claim 6
The system of claim 1, wherein an outer diameter of said cardiac lead extraction system is from about 5 mm to about 8 mm.
Claim 11
The system of claim 1, wherein:a. said elongated body comprises a first proximal end, a first distal end, and a third lumen extending from said first proximal end toward said first distal end, said third lumen sized and shaped to fit over a cardiac lead; and b. said bendable flexible portion comprises a second proximal end, a second distal end and said first lumen extending from said second proximal end toward said second distal end, said second lumen sized and shaped to fit over a cardiac lead.
Claim 11
The system of claim 1, wherein: a. said elongated body comprises a first proximal end, a first distal end, and a third lumen extending from said first proximal end toward said first distal end, said third lumen sized and shaped to fit over said cardiac lead; and b. said external bendable flexible portion comprises a second proximal end, a second distal end and said first lumen extending from said second proximal end toward said second distal end, said second lumen sized and shaped to fit over said cardiac lead.
Claim 12
The system of claim 1, further comprising one or more of a motor and a pedal; and wherein at least one of the following is true:a. said motor is located at said handle;b. said motor is located at said pedal;c. said pedal is used to activate and control said at least one lead extraction assistive tool.
Claims 13, 14, 15
The system of claim 12, wherein said motor is located at said handle.
The system of claim 12, wherein said motor is located at said pedal.
The system of claim 1, wherein said pedal is used to activate and control said at least one lead extraction assistive tool.
Claim 12 requires a motor and/or a pedal and at least one of a through c which the reference claims disclose.
Claim 17
The system of claim 1, wherein said handle is used to activate and control said at least one lead extraction assistive tool.
Claim 16
The system of claim 1, wherein said handle is used to activate and control said at least one lead extraction assistive tool.
Claim 18
The system of claim 1, wherein at least one lead extraction assistive tool comprises one or more components configured to perform repeatable movement at a repetition rate of from about 1Hz to about 100Hz; and wherein said repetition rate is from about 5Hz to about 60Hz.
Claim 18
17. The system of claim 1, wherein said at least one lead extraction assistive tool comprises one or more components configured to perform repeatable movement at a repetition rate of from about 1 Hz to about 100 Hz.
18. The system of claim 17, wherein said repetition rate is from about 5 Hz to about 60 Hz.
Claim 20
The system of claim 1, wherein said lead extraction assistive tool comprises a tissue cutter; and wherein said tissue cutter comprises one or more of:a. at least one movable blade;b. at least one transmission attached to said motor; said transmission adapted to transfer motion from said motor to said at least one movable blade;wherein at least one of the following is true:i. said motion of said at least one movable blade is linear;ii. said motion of said at least one movable blade is circular;iii. said movement of said transmission is configured to provide said at least one movable blade with a linear movement comprising an impact force to apply on the tissue;iv. said motion of said at least one movable blade is a combination of linear movement and circular movement;v. said motion of said at least one movable blade is characterized by a frequency from about 0.5Hz to about 100Hz;vi. said motion of said at least one movable blade is characterized by a frequency from about 1Hz to about 15Hz;vii. said at least one movable blade comprises a retracted state where said at least one movable blade is not exposed thereby minimizing said at least one movable blade from damaging tissue;viii. said at least one movable blade exits distally said operational distal end from about 0.15mm to about 2mm;ix. said tissue cutter comprises at least two movable blades;x. a relative movement of said at least two movable blades provides cutting by shearing.
Claims 22,23,24,25,26,27,29,30,31
19. The system of claim 1, wherein said at least one lead extraction assistive tool comprises a tissue cutter.
20. The system of claim 19, wherein said tissue cutter comprises at least one movable blade.
21. The system of claim 20, wherein said tissue cutter comprises at least one transmission attached to a motor; said at least one transmission adapted to transfer motion from said motor to said at least one movable blade.
22. The system of claim 21, wherein said motion of said at least one movable blade is linear.
23. The system of claim 21, wherein said motion of said at least one movable blade is circular.
24. The system of claim 21, wherein said motion of said at least one transmission is configured to provide said at least one movable blade with a linear motion comprising an impact force to apply on tissue.
26. The system of claim 21, wherein said motion of said at least one movable blade is characterized by a frequency from about 0.5 Hz to about 100 Hz.
27. The system of claim 21, wherein said motion of said at least one movable blade is characterized by a frequency from about 1 Hz to about 15 Hz.
28. The system of claim 21, wherein said at least one movable blade comprises a retracted state where said at least one movable blade is not exposed thereby minimizing said at least one movable blade from damaging tissue.
29. The system of claim 21, wherein said at least one movable blade exits distally said operational distal end from about 0.15 mm to about 2 mm.
30. The system of claim 19, wherein said tissue cutter comprises at least two movable blades.
31. The system of claim 30, wherein a relative movement of said at least two movable blades provides cutting by shearing.
The reference claims disclose that the lead extraction assistive tool is a tissue cutter and has at least one movable blade or and/or at least one transmission and at least one of i through x.
Claim 33
The system of claim 1, wherein said bendable portion comprises at least one internal structure configured to transmit motion from said handle to said operational distal end through said elongated body.
Claim 32
The system of claim 1, wherein said external bendable flexible portion comprises at least one internal structure configured to transmit motion from said handle to said operational distal end through said elongated body.
Claim 34
The system of claim 1, wherein said lead extraction assistive tool comprises a lead cutter.
Claim 33
The system of claim 1, wherein said lead extraction assistive tool comprises a lead cutter.
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, 3-6, 11, 17, 20, 33, 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 2019/0030324A1, “Grace”) in view of Smith et al. (US 2015/0150587A1, “Smith”).
Regarding claim 1, Grace discloses a cardiac lead extraction system (surgical device (106) for separating an implanted object, such as a pacemaker lead; Fig. 2; abstract), comprising: a. including a handle (108; Fig. 2), an elongated body (any portion of sheath assembly (3812) that is proximal segment (3844; Figs. 38-45A). The sheath assembly may replace sheath assembly (112; [0375]) in communication with the handle (Fig. 2). A bendable flexible portion interpreted as a distal end of sheath assembly that includes at least distal portion of (3844) and jacket (3828; Fig. 42) that is in communication with said elongated body (for example, at least rigid tube 3848; Fig. 42). The bendable flexible portion includes a first lumen (lumen of inner sheath 3820) sized and shaped to fit over a cardiac lead. It is noted that the device is used to separate a lead from the body (abstract). The bendable flexible portion is more flexible than the elongated body, wherein the flexible portion (3844) is more flexible than rigid portion (3848; Fig. 42; [0379-0380]). Furthermore, the distal portion of the outer member (3824) of the sheath assembly is more flexible than the proximal portion of the outer member due to the spacing and pitch of the cuts (Fig. 42). An operational distal end (distal end of sheath assembly near 3836; Fig. 38A) is in communication with said bendable flexible portion and includes at least one lead extraction assistive tool in the form of cutting tip (3832; Fig. 38A). The operational distal end includes a second lumen (lumen of cutting tip; Fig. 38A) that is sized and shaped to fit over a cardiac lead as the device is used to separate a lead from the body (abstract). The second lumen is in communication with said first lumen (Fig. 38A). The first lumen includes an inner diameter of from about 1mm to about 8mm since the inner diameter of the inner sheath includes the lumen (3820) which is about 0.119 inches to about 0.171inches (Table 1; i.e. 3.02 mm to 4.34 mm). Grace discloses inner sheaths with varying flexibility such that a distal portion of the bendable flexible portion is more flexible than the proximal portion (Figs. 42, 42A-42B; [00379]), but does not disclose that the bendable portion is capable of having a bending radius of less than 4cm while keeping said first lumen open.
In the same field of endeavor, flexible catheters, Smith teaches a flexible catheter including a bendable section that has the ability of bending in response to an applied bending force without breaking or deforming. The catheter may be deflectable as to have a bending radius of about 0.1 to about 2 in (0.245 cm to 5.08 cm), dependent on desires of the user and targeted bending stiffness [0044]. The catheter may have an inner diameter of 2.4 mm (the outer diameter of the tubular bendable catheter body may be desirably about 2.5 mm and include a wall thickness of 0.1 mm; [0048]), which is within the claimed inner diameter range and similar to that of Grace. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bendable flexible portion of Grace to have a bending radius of less than 4cm while maintaining lumen patency to access tortuous anatomy, as taught by Smith, to reach a desired bending radius ideal for a target site in the body while maintaining patency to provide means for inserting devices to procedure site. A person of ordinary skill in the art would have sought a smaller bending radius while maintaining lumen patency to access tortuous anatomy. Furthermore, Smith teaches suitable structures and ranges with predictable results. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Regarding claim 3, the combination of Grace and Smith discloses that the bendable flexible portion is capable of bending to a minimum bending radius of from about 2mm to about 15mm. The catheter may be deflectable as desired to have a bending radius of about 0.1inches to about 2 inches (2.45 mm to 50.8 mm), depending on the users desires and targeted bending stiffness [0044; Smith] which is within the claimed limitations of 2-15mm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the combination of Grace and Smith by providing the bendable flexible portion with a minimum bending radius of about 2mm to about 15mm, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 3, the combination of Grace and Smith discloses that the bendable flexible portion is capable of performing a movement from 0 degrees to about 180 degrees, wherein the flexible portion is bendable therefore bends at least 1 degree relative to the longitudinal axis of the device ([00383];Grace).
Regarding claim 4, the combination of Grace and Smith discloses that the bendable flexible portion includes at least one articulated structure in the form of a slotted bendable structure (Figs. 9A-9C; Smith; Fig. 42; Grace) and capable of maintaining first lumen open.
Regarding claim 5, the combination of Grace and Smith discloses a size of said inner diameter is selected from the group consisting of: a. from about 2mm to about 8mm; b. from about 2mm to 5mm; and c. from about 4mm to about 6mm (as the inner diameter of the inner sheath which includes the lumen of 3820 is about 0.119 inches to about 0.171inches; Table 1; i.e. 3.02 mm to 4.34 mm;Grace).
Regarding claim 6, the combination of Grace and Smith discloses an outer diameter of said cardiac lead extraction system is about 5mm to about 8mm, wherein the outer jacket diameter ranges from about 0.183inches to about 0.243inches. (Table 1; i.e. 4.65 mm to 6.17 mm; Grace).
Regarding claim 11, the combination of Grace and Smith discloses an elongated body includes first proximal and distal ends, a third lumen extends from the first proximal end toward the first distal end and is sized and shaped to fit over a cardiac lead. The bendable flexible portion includes second proximal and distal ends and the first lumen extends from the second proximal end toward the second distal end and is shaped to fit over a cardiac lead (Fig. 38-43; Grace).
Regarding claim 17, the combination of Grace and Smith discloses the handle (108) is used to activate and control the at least one lead extraction assistive tool via cam cylinder (420); [0166].
Regarding claim 20, the combination of Grace and Smith discloses the at least one lead extraction assistive tool includes a tissue cutter (632; Grace; [0375]). The tissue cutter comprises at least one movable blade in the form of a rotating blade (822) of cutting tip (632; [0160]; Grace). The tissue cutter (632) comprises at least one transmission (driven shaft) attached to a motor ([0166]). The at least one transmission is adapted to transfer motion from said motor to said at least one movable blade as the driven shaft is directly or indirectly coupled to the inner sheath to impart rotation thereto; [0166; Grace]. The at least one movable blade is linear since the blade moves both linearly (extending interpreted as moving longitudinally and parallel to sheath) and rotationally (Figs. 8A-8A’; [0160; Grace]). The at least one movable blade is circular (rotational; [0160, 0166]; Grace). The at least one transmission (driven shaft) is configured to provide said at least one movable blade with a linear motion that includes an impact force capable of being applied on the tissue as the cutting tip rotates and may also extend distally [0180; Grace].
Regarding claim 33, the combination of Grace and Smith that the bendable flexible portion (3844; Grace) includes at least one internal structure. The at least one internal structure is a structure attached to cutting tip (3832; Fig. 38A; Grace) and capable of transmitting motion from the handle to said operational distal end through the elongated body ([0166]; Grace).
Regarding claim 34, the combination of Grace and Smith discloses that the at least one lead extraction assistive tool includes a lead cutter, a cutting tip (3832) capable of cutting a lead from tissue (abstract).
Claim(s) 2, 35 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace in view of Smith, as applied to claim 1 above, and further in view of Osypka et al. (US 2015/0057610A1, “Osypka”).
Regarding claims 2, 35 and 43, the combination of Grace and Smith does not disclose a controllable steering mechanism capable of orienting the operational distal end, the controllable steering mechanism comprises at least one wire that runs from the handle to said operational distal end, and wherein said at least one wire runs inside a counter sleeve on the elongated body.
In the same field of endeavor, steering catheters, Osypka teaches a bendable catheter system (abstract) including a controllable steering mechanism capable of orienting the operational distal end. The controllable steering mechanism includes at least one wire (steering wires) that runs from the handle to the operational distal end (distal end of catheter). The at least one wire runs inside a counter sleeve (Figs. 1N1, 1N2) on the elongated body (Fig. 1M; [0010]). Osypka further teaches it was known to include steering mechanisms on conventional sheaths to allow the physician to deflect the distal portion of the sheath from about 35 degrees to about 150 degrees (Fig. 4A). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of the combination of Grace and Smith to include the steering mechanism as claimed, as taught by Osypka. to allow the physician to deflect the distal portion of the sheath to a maximal angle. Steering wires in counter-sleeves are standard for steering distal segments in minimally invasive devices; adding them to the combination of Grace and Smith predictably provides controlled tip orientation in lead extraction contexts.
Claim(s) 12, 36 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace in view of Smith, as applied to claim 1 above, and further in view of Brown et al. (US 2017/0360466A1, “Brown”).
Regarding claim 12, the combination of Grace and Smith discloses that the operational distal end (which includes the cutting tip) that is capable of continuously rotating, thereby allowing the cutting tip to continuously rotate [0188], but fails to disclose wherein said system comprises a pedal in communication with said handle, said pedal configured for activating said operational distal end such that the pedal is used to activate and control the at least one lead extraction assistive tool.
In the same field of endeavor, a tissue cutting system, Brown teaches a system (Figs. 1-7) comprising an operational distal end (distal end of the device including rotating cutting element at the distal end of the device) comprising at least one extraction assistive tool (cutting element) that is configured to continuously rotate via actuation of a motor (motor), similar to Grace. Brown teaches the system may comprise a handle (210; Fig. 1) including a motor (motor; [0042]) that drives the operational distal end (204) in a rotating and/or linearly back-and-forth motion to generate a cutting action [0042]. This action is similar to the continuous rotation and linear translation of the cutting tip of Grace. Brown also teaches an alternative embodiment (Figs. 6/7) in which the system includes a pedal (footswitch 300/1300) in communication with said handle (210/1210), said pedal configured for activating said operational distal end (as the footswitch activates and controls the cutting element 204; [0074]/[0083]). Integration of the pedal into the system results in a smaller footprint for the system and makes the system more portable and easier to set up and operate ([0007]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of the combination of Grace and Smith to include a motor located in the handle or pedal to activate and control the at least one lead extraction assistive tool, as taught by Brown, to provide a smaller footprint for the system and make the system more portable and easier to set up and operate. The combination of Grace and Smith discloses wherein said motor is located in the handle (as Brown teaches the motor may be located in either the handle in Figs. 5-6 or in the pedal in Fig. 7; [0008]). Brown’s use of a footswitch to control distal tools is reasonably pertinent to user ergonomics and workflow for surgical tools. A person of ordinary skill in the art would find it obvious to add a footswitch to free both hands and provide consistent control of rotation and/or translation.
Regarding claim 36, the combination of Grace and Smith discloses wherein said pedal comprises a battery (wherein the footswitch may include a battery; [0037]; [0076]; Brown), optionally a rechargeable battery (the battery may recharge as it can carry enough power for procedures within a predetermined time periods without recharging; [0037]; [ 0076]; Brown).
Regarding claims 36 and 37, the combination of Grace, Smith and Brown discloses that the system includes a battery, wherein the motor may be powered by a battery; ([0166; Grace;] [0006, 0046; 0058;Brown]), optionally a rechargeable battery. The battery may be in the footswitch/pedal or the motor.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace in view of Smith, as applied to claim 1 above, and further in view of Clopp et al. (US 2015/0327919A1, “Clopp”).
Regarding claim 18, the combination of Grace and Smith discloses wherein the at least one extraction assistive tool is a cutting tip that can continuously rotate and move linearly i.e. oscillate ([0188]), but fails to disclose wherein said at least one lead extraction assistive tool comprises one or more components configured to perform repeatable movement at a repetition rate of from about 1Hz to about 100Hz and/or from about 5Hz to about 60Hz.
In the same field of endeavor, a tissue cutting system, Clopp teaches an elongate body (914; Fig. 16), an operation distal end (distal end of 914) including at least one extraction assistive tool (inner blade shaft; [0124) that continuously rotates. The at least one extraction assistive tool includes one or more components configured to perform repeatable movement at a repetition rate of from about 2 Hz and 5 Hz, which is within and/or overlaps the claimed range (wherein the rotation oscillatory frequency is the speed at which something happens or changes, which is considered equivalent to a repetition rate; [0128]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the continuous repetition rate of the at least one lead extraction assistive tool of the combination of Grace and Smith to be from about 5Hz to about 60Hz as Applicant appears to have placed no criticality on the claimed range (see [0301] indicating the amount “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The claimed ranges overlap at 5Hz. A person of ordinary skill in the art would have had a reasonable expectation of success in selecting a repetition rate within known workable ranges absent criticality. In re Peterson, In re Woodruff, MPEP 2144.05.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tobis (US 2015/0374398A1) and Rousso et al. (US 2020/0352552A1) discloses lead extraction devices with bendable portions.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771