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 .
Election/Restrictions
This application contains claims directed to the following patentably distinct species:
Species I: Figures 1-6B (Wherein the operation device includes a movement detection unit with detecting rollers and a transmission unit with gears to automatically apply a moving force to the wire in a direction opposite to the detected movement of the housing, in combination with a limiting mechanism to restrict rotation of the rotating rollers).
Species II: Figures 7-9B (Wherein the operation device includes an action unit drive source (e.g., a motor) to drive the rotating rollers, controlled by operation switches to manually start and stop the drive source for moving the wire in distal or proximal directions).
Species III: Figures 10A-10C (Wherein the operation device lacks an action unit, movement detection unit, and transmission unit, and relies on manual securing of the wire to a target object combined with manual handling by the operator to move the wire relative to the housing.
Species I is read on claims 1-10; Species II is read on claims 11-19; Species III is read on claim 20. Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. No claim is generic because, for example, independent claims reciting a movement detection unit and transmission unit (as in Species I) exclude Species II and III; claims reciting a motorized drive source exclude Species I and III; and claim 20 recites no action unit, movement detection unit, or transmission unit and relies on manual securing/handling, excluding Species I and II.
If Species I is elected, applicant is further required to elect one sub-species from each of the following categories/limitations (each category/limitation represents a mutually exclusive variation disclosed as an alternative or modification within Species I).
The sub-species within Species I are mutually exclusive because each category (wire holding unit, limiting mechanism, action unit) presents structurally and functionally distinct alternatives that do not overlap (e.g., clip vs. rollers/belt vs. securing tool with claws; pivoting spring-biased member vs. deformable stopper; dual geared rollers vs. roller + rack plate vs. roller + fixed slippery plate), imposing distinct search burdens as the prior art relevant to one variation is unlikely to be pertinent to the others.
Species I encompasses the following sub-species:
Wire Holding Unit
Sub-species 1A: Figures 1-6B (Wherein the wire holding unit is an elastically deformable clip-shaped member disposed on the outer surface of the housing, rotatably holding the wire while bent in the distal direction and limiting longitudinal movement).
Sub-species 2A: Figures 11A-11B (Wherein the wire holding unit comprises either two holding rollers forming a holding space with the housing surface or a belt-like member with a hook-and-loop fastener or magnet).
Sub-species 3A: Figures 12-16B (Wherein the wire holding unit comprises a securing tool with a diameter-reducible portion and claws for gripping the wire, combined with a rotatable holding tool on the housing).
Limiting Mechanism
Sub-species 1B: Figures 1-6B (Wherein the limiting mechanism comprises a pivoting member (51) biased by a spring (55), with a protruding portion (53) that enters tooth grooves of a gear to prevent rotation of the rotating rollers, and a manually operable limiting operation portion (54)).
Sub-species 2B: Figure 17 (Wherein the limiting mechanism comprises an elastically deformable stopper that restricts rotation of the gears with a predetermined holding force and automatically releases under excessive force).
Action Unit
Sub-species 1C: Figures 1-6B (Wherein the action unit comprises two rotating rollers symmetrically arranged to pinch the wire, with rubber/non-slip outer peripheral surfaces, rotated in opposite directions via meshing gears linked to the movement detection unit).
Sub-species 2C: Figure 18 (Wherein the action unit comprises one rotating roller combined with a linearly moving plate member driven by a rack).
Sub-species 3C: Figure 19 (Wherein the action unit comprises one rotating roller combined with a fixed securing plate having a slippery sliding surface).
The species (and sub-species within Specie I) are independent or distinct because they have mutually exclusive characteristics. In addition, these species and sub-species are not obvious variants of each other based on the current record.
There is a serious search and/or examination burden for the patentably distinct species and sub-species as set forth above because at least the following reason(s) apply: The disclosed species and sub-species require different modes of operation, different structural elements, and distinct search strategies/classifications (e.g., Species I implicates CPC A61B 2017/3207 and F16H for mechanical feedback/transmission systems; Species II implicates A61B 17/34 combined with H02K/H02P for motorized handpiece controls; Species III implicates A61B 2017/34 and A61M 25/10 for manual guidewire handling and clamping; sub-species variations further diverge in search fields for specific holding, limiting, or action mechanisms); and/or the prior art applicable to one species (and sub-species) would not likely be applicable to another species (and sub-species) because, for example, automatic mechanical feedback systems are searched in distinct control and gearing arts that rarely overlap with purely manual or motorized control workflows.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species (and, if Species I is elected, one sub-species from each category/limitation: Wire holding unit, limiting mechanism, and action unit) to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species (or elected species/sub-species combination) or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Kirk M. Nuzum on 02/05/2026 a provisional election was made without traverse to prosecute the invention of Species III, claim 20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-19 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/26/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because:
Figures 6A-6B include reference number “(55)” which as disclosed is the biasing member/spring. In Figures 6A-6B, reference number “(55)” does not appear to be pointing to a biasing member/spring as shown in an earlier figure, specifically (see element 55 and specification paragraph [0081] for the spring); instead, in Figs. 6A-6B it appears to point to limiting member (51) or limiting operation portion (54), which is inconsistent with the disclosure.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Figures 10A-10C, reference number “(401)”. Applicant should add this reference character to the detailed description (at the appropriate paragraph(s)) in a manner supported by the as-filed disclosure without introducing new matter or cancel the reference number entirely from the figures.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0008] should be amended to the following, “(1) An operation device according to the present disclosure is an operation device configured to be joined with a proximal portion of an elongated treatment device having a lumen through which a wire extending from an indwelling unit indwelling in a living body lumen, the operation device includes: a housing including a joining portion configured to be joined to the proximal portion of the treatment device; and an action unit that is disposed on the proximal side of the joining portion, and wherein the action unit is configured to be brought into contact with the wire extending from the proximal portion of the treatment device, to apply, to the wire, a moving force for the wire to move in a longitudinal axis direction.”
Paragraph [0081] should be amended to the following, “The limiting mechanism 50 is a mechanism that limits rotation of the rotating rollers 41. As illustrated in FIG. 3, the limiting mechanism 50 can include: a limiting member 51 that can be rotated with respect to the housing 20 by a fulcrum 52; and a biasing member 55 that biases the limiting member 51. On one end side of the limiting member 51, a protruding portion 53 that can enter the tooth grooves of the third gear 73 (or the second gear 72) and retract from the tooth grooves is formed. On the opposite side of the fulcrum 52 from the protruding portion 53, a limiting operation portion 54 that protrudes outwardly from the housing 20 and can be operated by the operator is formed. The biasing member 55 can be a spring member, for example, and has one end secured to the housing 20, and the other end secured to the limiting member 51. The biasing member 55 biases the limiting member 51 so that the protruding portion 53 of the limiting member 51 moves toward the tooth grooves of the third gear 73. With the limiting member 51 being biased by the biasing member 55, the protruding portion 53 enters the tooth groove of the third gear 73. With this arrangement, the rotating rollers 41 become unable to rotate, and the wire 320 in contact with the rotating rollers 41 becomes unable to move with respect to the housing 20. When the operator presses the limiting operation portion 54, the limiting member 51 rotates about the fulcrum 52 against the biasing force of the biasing member 55, and the protruding portion 53 retracts from the tooth grooves of the rotating rollers 41. With this arrangement, the rotating rollers 41 become able to rotate, and the wire 320 in contact with the rotating rollers 41 becomes able to move with respect to the housing 20. When the operator takes his/her hand off the limiting operation portion 54, the limiting member 51 rotates by the biasing force received from the biasing member 55, and the protruding portion 53 enters the tooth grooves of the third gear 73. With this arrangement, the rotating rollers 41 become unable to rotate, and the wire 320 in contact with the rotating rollers 41 becomes unable to move with respect to the housing 20.”
Paragraph [0146] should be amended to the following, “The detailed description above describes an operation device for operating a treatment device inserted into a living body lumen, and a method of operating a medical care system. The invention is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents can be effected by one skilled in the art without departing from the spirit and scope of the invention as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.”
The suggested amendments are illustrative only and must be supported by the as-filed disclosure to avoid introduction of new matter (35 U.S.C. 132(a)). Appropriate correction is required.
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 should be amended to the following to maintain consistency of how the limitation is recited throughout the claim, “A method of operating a medical care system that includes an indwelling device having an indwelling unit configured to be indwelled in a living body lumen, and a wire extending from the indwelling unit; an elongated treatment device having a lumen through which the wire passes, and an operation device that has a proximal portion of the elongated treatment device, the operation device configured to be joined to the elongated treatment device and to operate the elongated treatment device, the method comprising:
inserting the elongated treatment device into the living body lumen while the wire extending from the indwelling unit indwelling in the living body lumen to outside of the living body is accommodated in the lumen;
securing the wire extending from the operation device to a surgical table or a securing target object that is an object placed on the surgical table;
maintaining the securing of the wire to the surgical table or the securing target object when the operation device is moved in a distal direction; and
when the operation device is moved in a proximal direction, the wire is moved in the distal direction with respect to the operation device.”
Appropriate correction is required.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swainston (US PGPUB No. 20040220612 A1), in view of Hoek (US PGPUB No. 20110147542 A1), and further in view of Wulfman (US Patent No. 8435228 B2).
Regarding claim 20, Swainston discloses, a catheter having a capture mechanism that can be actuated to capture and to retrieve a filter-type embolic protection device. Swainston teaches, a method of operating a medical care system (Figure 1, capture catheter (100); Paragraph [0053], “…capture catheter 100 can be used to capture an embolic protection device that collects embolic material during an interventional procedure.”) that includes an indwelling device having an indwelling unit (Figures 6A-6B, filter (152); Paragraph [0106]) configured to be indwelled in a living body lumen (Paragraph [0106], “Capture catheter 100 then stops at the predetermined location at which a filter 152 or other embolic protection device is located in the blood vessel.”), and a wire (Figures 6A-6B, guide wire (150); Paragraph [0105]) extending from the indwelling unit (Figures 6A-6B; Paragraphs [0105]-[0107]); an elongated treatment device (Figures 1-3, tubular member (106); Paragraph [0055]) having a lumen (Figures 1-3, guide wire lumen (126)) through which the wire passes (Paragraph [0069]), and an operation device (Figures 1-2, actuation assembly (110) which is comprised of barrel (112) and plunger (116); Paragraphs [0055]-[0056]) that has a proximal portion of the elongated treatment device (Figures 1-2, show actuation assembly (110) at proximal end (102), joined to tubular member (106)), the operation device configured to be joined to the elongated treatment device and to operate the elongated treatment device (Paragraph [0055], “… actuation assembly 110 is disposed at proximal end 102 … selectively displace capture sleeve 108 in the proximal and/or distal directions.” Paragraph [0056], “Moving plunger 116 relative to barrel 112 causes a deploying member 120 to move relative to tubular member 106.”), the method comprising:
inserting the elongated treatment device (tubular member (106)) into the living body lumen while the wire (guide wire (150)) extending from the indwelling unit (filter (152)) indwelling in the living body lumen to outside of the living body is accommodated in the lumen (lumen (126)) (Figure 6A shows catheter (100) advanced over guide wire (150) with filter (152) already indwelled; Paragraph [0105], “The guide wire 150 leads the capture catheter 100 as it is maneuvered and navigated through the blood vessels.” and Paragraph [0106], “Capture catheter 100 then stops at the predetermined location at which a filter 152 … is located in the blood vessel …”); and when the operation device (actuation assembly (110)) is moved in a proximal direction, the wire (guide wire (150)) is moved in the distal direction with respect to the operation device (as the capture sleeve is retracted proximally to release the filter (see operation description and FIGS. 6A-6B), the fixed guidewire/filter relatively advances distally relative to the retracting sleeve and actuation assembly; see also Paragraphs [0026]-[0027] regarding plunger retraction to release and subsequent removal of the catheter including the guidewire).
Swainston does not expressly disclose securing the wire extending from the operation device to a surgical table or a securing target object that is an object placed on the surgical table; and maintaining the securing of the wire to the surgical table or the securing target object when the operation device is moved in a distal direction.
Wulfman discloses interventional catheter assemblies that operate over a guide wire. Wulfman teaches securing the wire extending from the operation device (Col. 2, lines 48-52: "A guide wire brake or clamp is generally provided ... permitting the operator to clamp the guide wire in a fixed position.") and maintaining the securing when the operation device is moved in a distal direction (Col. 2, line 57 – Col. 3, line 11 and Col. 5, lines 52-67: the guide wire is typically clamped prior to advancing the interventional catheter, with excess guide wire that is exposed as the interventional catheter is advanced distally generally accumulating in a buffer zone; the clamp maintains the wire fixed during such advancement).
When the clamped guide wire is fixed and the operation device/catheter is moved proximally, the wire necessarily moves distally relative to the operation device as the device retracts along the stationary wire (see Wulfman, Col. 2, line 57 – Col. 3, line 11: retraction takes up accumulated excess wire, exposing more distally).
Hoek discloses a cable organizer. Hoek teaches a securing target object (Figure 1, cable organizer (10); Paragraph [0050]) that is an object placed on the surgical table/work surface (Paragraph [0050], "... wherein the bottom surface is adapted for placement upon a work surface..."), wherein the device/securing target object secures a protruding wire/cable and the securing is maintained during movement/manipulation (Paragraph [0050], "... top surface 28, wherein the top surface comprises at least one aperture 30 for receiving cable 32 ... tabs 34 which are controllably bendable... cable 32 is retained in cable channel 36 during normal use..."). While Hoek is directed to general cable management, it is analogous art for the problem of managing elongated flexible members on a work surface to prevent unintended movement.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Swainston’s method by securing/clamping the proximal guidewire as taught by Wulfman (and alternatively or additionally using a table-placed organizer as in Hoek) to prevent unintended proximal wire movement, dislodging, or shifting during catheter manipulation—a standard practice in interventional procedures. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Swainston’s method by clamping the proximal guidewire as taught by Wulfman (and using a table-mounted organizer as taught by Hoek) because all the references and the claimed invention are directed to managing/securing elongated flexible members in medical interventions. Such a modification would have been a predictable application of known guidewire management techniques (KSR) to stabilize the wire during advancement and retraction of the operation device, with the buffer zone in Wulfman explicitly accommodating the relative distal wire movement when the device is retracted proximally while the wire remains secured.
The combination yields the recited steps with no more than predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OSAMA NEMER whose telephone number is (571)272-6365. The examiner can normally be reached Monday-Friday 7:30-5:00.
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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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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771