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 .
Response to Arguments
The previous rejection of claim(s) 5 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 5 on 3/18/2026.
Applicant's arguments filed 3/18/2026 over Grace et al. (US 2019/0030324 A1) in view of Slobitker et al. (US 9,826,985 B2) have been fully considered but they are not persuasive.
Applicant argues the examiner has selectively extracted a single teaching from Slobitker while ignoring the fundamental operating principle because Slobitker teaches that the link dimensions “may be preselected” while ignoring Slobitker’s invention is directed to a system in which a user adds or removes links in real time to adjust the flexible portion. The examiner agrees that in some instances the device of Slobitker is intended to be adjusted in real time. However, this fact does not take away from the teachings in Slobitker that indicate that the device does not need to be used in real time, but may, alternatively, be adjusted prior to use. For example, in column 19, lines 3-6, Slobitker recites “In some embodiments, adjustment of the flexible bone tool is performed prior to the procedure. Additionally or alternatively, adjustment is performed during the procedure, for example if a need for a longer or shorter tool rises.” While the device of Slobitker generally may be adjusted in length during a procedure by retracting the device from the body, adjusting the length of the device, and reinserting the device into the body (column 19, lines 6-9), this does not refute the fact that Slobitker also teaches the length of the device may be preselected and adjusted prior to use. Multiple embodiments can exist and be mutually exclusive. Nonpreferred or alternative embodiments, such as preselecting/adjusting the length of the device of Slobitker, are still relevant prior art and do not automatically teach away from the claimed invention.
Applicant argues that Slobitker’s link system is stripped away from real-time adjustment and covered with the outer jacket (3828) of Grace so that the links of Slobitker are permanently inaccessible. This is a misconstruction of the rejection. The links of Slobitker are not being modified to include the outer jacket of Grace. Instead, the bendable flexible inner sheath (3844) of Grace, which is already covered by an outer jacket (3828), is being modified in light of the teachings of Slobitker to bend to a particular bending radius while keeping the first lumen of the inner sheath open and being configured to transmit a specific torque.
The above noted preselection taught by Slobitker also refers to selection for a certain bending radii. Slobitker recites “In some embodiments, one or more dimensions of a link are selected to provide for a certain bending radii range of a tubular body comprising a plurality of links.” in column 17, lines 62-64. Slobitker further recites “said links define a tubular body configured to bend into a bending radius of 30 mm or higher” in column 29, lines 25-27. Thus, Slobitker teaches it was known to one of ordinary skill in the art to have a bendable flexible portion in which dimensions may be preselected to result in a bending radius of 3 cm. A preselected bending radius is separate from and independent of the need to adjust the length of the flexible bendable portion in real time and Slobitker does not teach that the ability to adjust the device in real time is necessary for the flexible bendable portion to have the taught bending radius. Therefore, a person of ordinary skill in the art would reasonably adapt the teachings of Slobitker independently of the desire for adjusting the length of the device of Slobitker in real time. The same argument applies to the specific torque taught by Slobitker.
Accordingly, modifying Grace’s flexible bendable portion, which is a slotted/cut structure with the predetermined links dimensioned to have a bending radius of 3 cm while keeping the first lumen of the inner sheath open and being configured to transmit a torque of at lest 10 N*cm would not eliminate the only feature of Slobitker that distinguishes Slobitker from any other flexible structure because the links of Slobitker are not being used in a way that Slobitker never contemplated, they are being used to provide a particular bending radius and torque.
The key issue is whether the proposed modification would render the reference being modified i.e., Grace unsatisfactory for its intended purpose not where in Slobitker there is any teaching, suggestion, or motivation to permanently encase the articulated links of Slobitker. In the instant case, modifying the encased bendable flexible portion of Grace to have the claimed bending radius and torque as taught by Slobitker would not inhibit the use of the device of Grace. Instead, it would increase the flexibility of the bendable flexible portion making the device more easily maneuvered through the body.
With respect to applicant’s arguments that Slobitker’s preselection is for real time adjustment, it is again noted that modifying Grace’s bendable flexible portion to have a specific preselected bending radius taught by Slobitker would not require any real time adjustment as the two are separate and independent features.
Applicant argues that even if one accepts that Slobitker teaches that link dimensions can be preselect for a fixed configuration, this still does not provide motivation for replacing Grace’s slotted/cut flexible structure with Slobitker’s links, permanently covering those links with Grace’s outer jacket, and achieving simultaneously a bending radius of less than 4 cm, maintain the first lumen open, and torque transmission of at least 10 N*cm. The examiner respectfully disagrees.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, motivation can be found at least in Slobitker. For example, Slobitker recites “one or more dimensions of a link are selected to provide for a certain bending radii range of a tubular body comprising a plurality of links” for “a more flexible tubular body which is configured to bend into smaller bending radii” and optionally, selecting the link dimensions for example as described would result “so that during bending the extensions will be more free to move around in the recess and allow a higher degree of flexion of the tubular body” (columns 17-18, lines 61-67, 1-15). The lumen of the tubular body would remain open during bending as shown in Fig. 3A. Slobitker further teaches matching geometries of subsequent links are suitable for transferring torque between said links at a magnitude sufficient for advancing sufficient for advancing the device into a bone, wherein “the magnitude of torque ranges between 3 N*cm to 30 N*cm” (column 29, lines 11-17). Thus, Slobitker teaches preselecting the bending radius would increase flexibility to allow for a higher degree of flexion of the tubular body and torque in the claimed range would be sufficient for advancing the device into bone. Motivation is not necessary for permanently covering the links of Slobitker with Grace’s outer jacket because Slobitker is not being modified, Grace is.
Applicant argues Slobitker’s articulated links are not interchangeable dimensional parameters that can be sized to fit into Grace’s sheath assembly and instead would require redesigning the inner diameter of Grace’s sheath assembly to accommodate Slobitker’s link geometry while maintain the required first lumen dimensions, ensuring Grace’s outer jacket does not constrain the articulation links, verifying the link-to-link interface provides sufficient torque transmission and ensuring lumen patency is maintained. Applicant’s argument is not found persuasive because both Grace and Slobitker teach bendable flexible tubes and one of ordinary skill would understand and be able to replace a slotted/cut tube with a linked tube. Because the slotted/cut tube of Grace is able to be covered with a jacket and bend without kinking or preventing the flexible bendable portion from bending, then one of ordinary skill in the art would expect the same to be true with Grace’s modified bendable flexible portion.
Applicant argues that the examiner has not addressed at least one structure be configured to simultaneously: keep the first lumen open, bend to a bending radius of less than 4 cm, and transmit a torque of at least 10 N*cm. The examiner respectfully disagrees. Slobitker teaches a bendable flexible portion with all of these characteristics as noted in the rejection below. Slobitker teaches a bendable flexible portion (tubular body 3002; Fig. 3A), wherein said bendable portion is configured to bend to a bending radius of less than 4cm (30mm i.e. 3cm; claim 13) while keeping said first lumen open (Fig. 3A), wherein said bendable flexible portion comprises at least one articulated structure (links 3012) configured to provide said keeping said first lumen open; said at least one articulated structure is further configured to transmit a torque of at least 10 [N*cm] to said at least one lead extraction assistive tool also while performing said bending and also while performing said keeping said first lumen open (torque ranges between 3 N*cm to 30 N*cm; claims 9-10). Thus, Slobitker does in fact teach these performance requirements concurrently.
Applicant argues that if Grace already discloses an outer jacket covering a bendable flexible portion with at least one structure, then the examiner must explain what Slobitker adds to the combination that Grace does not already provide. As discussed above and the in rejection below, Slobitker teaches a bendable flexible portion that has a bending radius of 3 cm while keeping the lumen thereof open and transmits torque at 10 N*cm. The bendable flexible portion of Grace is modified in light of the teachings of Slobitker to include these features in order to increase the flexibility of the bendable flexible portion of Grace.
Applicant argues when the links of Slobitker are permanently encased under Grace’s outer jacket, the performance characteristics of Slobitker’s link system with be altered by the constraining effect of the outer jacket. It is the examiner’s position that the bendable flexible portion of Grace that is covered by the jacket is intended to bend and flex and the jacket does not inhibit movement or kink within the slotted/cut outs of the bendable flexible portion of Grace. Therefore, one of ordinary skill in the art would expect the same to be true when the slotted/cut outs of Grace are modified to be the links of Slobitker.
Applicant’s arguments with respect to Sheldon (US 3,060,972) are moot as Sheldon is not being used in the present rejection. Instead, Sheldon was noted as prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure for the reasons explained in the conclusion section of the Non-Final Rejection mailed 12/18/2025. Accordingly, arguments with respect to Sheldon are not found persuasive.
For at least the reasons discussed above, applicant’s arguments are not found persuasive and rejections over Grace in view of Slobitker have been maintained..
Claim Interpretation
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.
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.
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 in claim 2.
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 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-6, 9, 12-13, 17, 20-26, 29-34, 81-82 and 84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 2019/0030324 A1) in view of Slobitker et al. (US 9,826,985 B2).
Regarding claims 1 and 84, 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. a handle (handle assembly 108; Fig. 2); b. an elongated body (any portion of sheath assembly 3812 proximal segment 3844; Figs. 38-45A; wherein sheath assembly 3812 may replace sheath assembly 112; [0375]) in communication with said handle (Fig. 2); c. a bendable flexible portion (distal end of sheath assembly 3812 including at least distal portion of 3844; Fig. 42) in communication with said elongated body (for example, at least rigid tube 3848; Fig. 42), said bendable flexible portion comprising a first lumen (lumen of inner sheath 3820) sized and shaped to fit over a cardiac lead (as the device is used to separate a lead from the body; abstract); said bendable flexible portion being more flexible than said elongated body (as the flexible portion 3844 is more flexible than rigid portion 3848; further, the distal portion of the outer member is more flexible than the proximal portion of the outer member due to the spacing and pitch of the cuts; Fig. 42); d. an operational distal end (distal end of sheath assembly near 3836; Fig. 38A) in communication with said bendable flexible portion; and wherein said operational distal end comprises at least one lead extraction assistive tool (cutting tip 3832), said operational distal end comprising a second lumen (lumen of cutting tip 3832; Fig. 38A) sized and shaped to fit over a cardiac lead (as the device is used to separate a lead from the body; abstract), said second lumen being in communication with said first lumen (Fig. 38A), and said first lumen comprises an inner diameter of from about 1mm to about 8mm (as the inner diameter of the inner sheath which includes the lumen of 3820 is about 0.119 in to about 0.171 in; Table 1; i.e. 3.02 mm to 4.34 mm). Grace discloses wherein said cardiac lead extraction system further comprises an external cover (outer jacket 3828; Fig. 38A) extending along said elongated body and covering said bendable flexible portion including at least one bendable structure (Figs. 38A, 39).
Grace teaches 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 fails to explicitly disclose wherein said bendable portion is configured to bend to a bending radius of less than 4cm while keeping said first lumen open, wherein said bendable flexible portion comprises at least one structure configured to provide said keeping said first lumen open; said at least one structure is further configured to transmit a torque of at least 10 [N*cm] to said at least one lead extraction assistive tool also while performing said bending and also while performing said keeping said first lumen open.
However, Slobitker teaches a bendable flexible portion (tubular body 3002; Fig. 3A), and an operational distal end comprising at least one extraction assistive tool (cutting head 3004), wherein said bendable portion is configured to bend to a bending radius of less than 4cm (30mm i.e. 3cm; claim 13) while keeping said first lumen open (Fig. 3A), wherein said bendable flexible portion comprises at least one articulated structure (links 3012) configured to provide said keeping said first lumen open; said at least one articulated structure is further configured to transmit a torque of at least 10 [N*cm] to said at least one lead extraction assistive tool also while performing said bending and also while performing said keeping said first lumen open (torque ranges between 3 N*cm to 30 N*cm; claim 10). Slobitker teaches the bending radius is determined by length and dimensions of the bendable portion (via link dimensions and lengths) and the user may select these dimensions to provide a certain bending radii range (columns 17-18, lines 62-67, 1-15).
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 at least one structure of the bendable flexible portion of Grace to have a predetermined bending radius of less than 4cm while keeping said first lumen open and being configured to transmit a torque as claimed in light of the teachings of Slobitker in order to increase the flexibility of the bendable flexible portion making the device more easily maneuvered through the body.
Regarding claim 3, modified Grace discloses fails to explicitly disclose said bendable flexible portion is configured to bend to a minimum bending radius of from about 2mm to about 15mm.
However, Slobitker teaches the bending radius can be 20 mm or smaller (column 14, lines 43-58).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the minimum bending radius of modified Grace to about 15 mm as applicant appears to have placed no criticality on the claimed range (see pp. [0399] indicating the bending radius is “optionally” 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).
Regarding claim 4, modified Grace discloses wherein said bendable flexible portion comprises at least one articulated structure (linked bendable structure taught by Slobitker; Fig. 3A; and or slotted bendable structure taught by Grace; Fig. 42) configured to maintain said first lumen open.
Regarding claim 5, Grace modified discloses the invention as claimed above, and Grace further discloses wherein a size of said inner diameter of said second lumen 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 in to about 0.171 in; Table 1; i.e. 3.02 mm to 4.34 mm).
Regarding claim 6, Grace modified discloses the invention as claimed above, and Grace further discloses wherein an outer diameter of said cardiac lead extraction system is from about 5mm to about 8mm (outer jacket diameter ranges from about 0.183 in to about 0.243 in; Table 1; i.e. 4.65 mm to 6.17 mm).
Regarding claim 9, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said bendable flexible portion is configured to perform 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).
Regarding claim 12, Grace modified discloses the invention as claimed above, and Grace further discloses a motor (wherein the actuation means may comprise an electric motor; [0166]).
Regarding claim 13, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said motor is located at said handle (as the handle assembly may comprise a motor; [0166]). It is further noted that Brown teaches the motor in conjunction with the pedal may be located in said handle (Figs. 5-6).
Regarding claim 17, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said handle (108) is used to activate and control said at least one lead extraction assistive tool (via cam cylinder 420; [0166]).
Regarding claim 20, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said lead extraction assistive tool comprises a tissue cutter (cutting tip 632).
Regarding claim 21, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said tissue cutter comprises at least one movable blade (rotating blade 822 of cutting tip 632; [0160]).
Regarding claim 22, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said tissue cutter (632) comprises at least one transmission (driven shaft) attached to a motor ([0166]); said at least one transmission 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]).
Regarding claim 23, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said motion of said at least one movable blade is linear (as the blade moves both linearly and rotationally; Figs. 8A-8A’; [0160]).
Regarding claim 24, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said motion of said at least one movable blade is circular (rotational; [0160]; [0166]).
Regarding claim 25, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said motion of said at least one transmission (driven shaft) is configured to provide said at least one movable blade with a linear motion comprising an impact force to apply on the tissue (as the cutting tip rotates, it may also extend distally; [0180]).
Regarding claim 26, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said motion of said at least one movable blade is a combination of linear movement and circular movement (as the cutting tip rotates, it may also extend distally; [0180]).
Regarding claim 29, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said at least one movable blade comprises a retracted state (Fig. 8A).
Regarding claim 30, Grace modified discloses wherein said at least one movable blade exists distally from said operation distal end (Figs. 8A-8A’) but fails to explicitly disclose wherein said at least one movable blade exits distally said operational distal end from about 0.15mm to about 2mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the blade of modified Grace to exit distally from the operational distal end from about 0.15mm to about 2mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of modified Grace would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed, indicating simply that the distance is “about” the claimed range.
Regarding claim 31, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said tissue cutter (632) comprises at least two movable blades (at least two of the scalloped blades 822; Fig. 8A).
Regarding claim 32, Grace modified discloses the invention as claimed above, and Grace further discloses wherein a relative movement of said at least two movable blades (at least two of the scalloped blades 822; Fig. 8A) provides cutting by shearing (as tissue is sheared as 632 is rotated relative to tissue).
Regarding claim 33, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said bendable flexible portion (3844) comprises at least one internal structure (structure attached to 3832; Fig. 38A) configured to transmit motion from said handle to said operational distal end through said elongated body ([0166]).
Regarding claim 34, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said lead extraction assistive tool comprises a lead cutter (cutting tip 3832 which is capable of cutting a lead from tissue; abstract).
Regarding claim 81, Grace modified discloses the invention as claimed above, and Grace further discloses where said at least one movable blade is not exposed thereby minimizing said at least one movable blade from damaging tissue (Fig. 8A).
Regarding claim 82, Grace modified discloses the invention as claimed above, and Grace further discloses wherein said system comprises a battery (as the motor may be powered by a battery; [0166]), optionally a rechargeable battery.
Claim(s) 2, 7-8 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 2019/0030324 A1) in view of Slobitker et al. (US 9,826,985 B2), as applied to claim 1 above, and further in view of Osypka et al. (US 2015/0057610 A1).
Regarding claims 2, 7 and 35, modified Grace fails to disclose wherein said system further comprises a controllable steering mechanism configured to orient said operational distal end, wherein said controllable steering mechanism comprises at least one wire that runs from said handle to said operational distal end, and wherein said at least one wire runs inside a counter sleeve on said elongated body, wherein said bendable flexible portion bends to a maximal angle of from about 35 degrees to about 150 degrees.
However, Osypka teaches a bendable catheter system (abstract) comprising a controllable steering mechanism configured to orient said operational distal end, wherein said controllable steering mechanism comprises at least one wire (steering wires) that runs from said handle to said operational distal end (distal end of catheter), and wherein said at least one wire runs inside a counter sleeve (Figs. 1N1, 1N2) on said elongated body (Fig. 1M; [0010]). Osypka 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).
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 modified Grace to include the steering mechanism as claimed in light of the teachings of Osypka in order to allow the physician to deflect the distal portion of the sheath to a maximal angle.
Regarding claim 8, modified Grace fails to explicitly disclose wherein an inner diameter of said bendable flexible portion changes in length from about 0% to about 10% during said maximal angle. However, when bent, the diameter taken at the bend would be changed.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the inner diameter of modified Grace to change from about 0% to about 10% since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of modified Grace would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed, indicating simply that the length is “about” the claimed range.
Claim(s) 14-16 and 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 2019/0030324 A1) in view of Slobitker et al. (US 9,826,985 B2), as applied to claim 1 above, and further in view of Brown et al. (US 2017/0360466 A1).
Regarding claims 14 and 16, Grace discloses that the operational distal end (which includes the cutting tip) can be configured to continuously rotate (as the cam slot may have an open and continuous configuration, thereby allowing the cutting tip to continuously rotate; [0188]) with a motor (wherein the actuation means may comprise an electric motor; [0166]) 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 said at least one lead extraction assistive tool.
However, 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) comprising a motor (motor; [0042]) that drives the operational distal end (cutting element 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 comprises 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]).
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 modified Grace to include a pedal in communication with the handle, the pedal configured for activating the operational distal end to activate and control the at least one lead extraction assistive tool as taught by Brown in order to provide a smaller footprint for the system and make the system more portable and easier to set up and operate.
Regarding claim 15, Grace modified discloses wherein said motor is located at said pedal (as Brown teaches the motor may be located in either the handle in Figs. 5-6 or in the pedal in Fig. 7; [0008]).
Regarding claim 83, Grace modified discloses wherein said pedal comprises a battery (wherein the footswitch may include a battery; [0037]; [0076]), 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]).
Claim(s) 18-19 and 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 2019/0030324 A1) in view of Slobitker et al. (US 9,826,985 B2), as applied to claim 1 above, and further in view of Clopp et al. (US 2015/0327919 A1).
Regarding claims 18-19, Grace 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 modified Grace 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.
However, Clopp teaches a system comprising an elongate body (914; Fig. 16), an operation distal end (distal end of 914) comprising at least one extraction assistive tool (inner blade shaft; [0124) that continuously rotates, wherein said at least one extraction assistive tool comprises 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]).
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 modified Grace 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).
Regarding claims 27-28, Grace discloses wherein the at least one extraction assistive tool is a cutting tip comprising at least one movable blade that can continuously rotate and move linearly i.e. oscillate ([0188]), but modified Grace fails to disclose wherein said motion of said at least one movable blade is characterized by a frequency from about 0.5Hz to about 100Hz and/or from about 1Hz to about 15Hz.
However, Clopp teaches a system comprising an elongate body (914; Fig. 16), an operation distal end (distal end of 914) comprising at least one extraction assistive tool comprising at least one movable blade (inner blade shaft; [0124) that continuously rotates at a frequency from about 2 Hz and 5 Hz ([0128]), which is within the claimed range.
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 frequency of the at least one movable blade of modified Grace to be from about 1Hz to about 15Hz as Applicant appears to have placed no criticality on the claimed range (see [0271] indicating the amount is “optionally” 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).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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