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 Objections
Claims 1-3 and 18 are objected to because of the following informalities:
Claim 1 line 9 “the device” should recite “the medical device”.
Claim 2 line 2 “the guidewire being between” should recite “the guidewire positioned between”.
Claim 3 line 2 “the rigid member being between” should recite “the rigid member positioned between”.
Claim 18 line 3 “the guidewire being between” should recite “the guidewire positioned between”.
Appropriate correction is required.
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: “the interactive features of the guidewire interacting with the rigid member to produce user-perceptible vibrations” in claims 1 and 17.
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.
The interactive features are defined, in para. [0023, 0052-0053, 0060-0063], as differences in guidewire diameter, surface features, surface characteristics, composition, construction, transitional features between segments of the guidewire, ridges, grooves, surface roughness.
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 (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.
Claims 1, 4, 9-10,14-15, 17, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mottala (US 6059759 A) in view of Bagaoisan (US 20140018732 A1).
Regarding claim 1, Mottola discloses a tactile-feedback system for a guidewire-containing medical device (Abstract, col. 4 lines 13-64 & col. 12 lines 45-55, figs. 1 & 14-15), comprising: a guidewire (occluding wire 22, figs. 14-15, “guide wire”, col. 4 lines 53-64 & col. 12 lines 45-55) including interactive features (spring wire 292 forming ridge 295 and groove 296 , figs. 14-15, “ridges projecting therefrom”, col. 4 lines 53-64 & col. 13 line 63 – col. 14 line 3); and a rigid member (sensing ridge 276, fig. 13, “nylon ... shore 70D”, col. 11 lines 30-43 & col. 13 lines 35-62) in vibratory communication with a handholdable portion (proximal end 252, figs. 7 & 12-15) of the medical device (figs. 7 & 12-15, “transmit vibrations along the occluding wire 22 when occluding wire 22 is advanced within the lumen of infusion catheter 18”, col. 4 lines 13-64 & col. 13 lines 25 – col. 14 line 3), the interactive features of the guidewire interacting with the rigid member (“292 interact ... 276 ... rubbing ... ridges projecting therefrom”, col. 13 lines 25 – col. 14 line 3, fig. 15) to produce user-perceptible vibrations in the guidewire or the handholdable portion of the medical device as the guidewire moves against the rigid member while being advanced out of the medical device or retracted into the device (“tactually feel these vibrations ... transmit vibrations along occluding wire 22 ... advanced”, col. 13 lines 25 – col. 14 line 3), thereby providing tactile feedback to a user of the medical device indicating a status of the guidewire with respect to a patient or the medical device (“actually feel when the occluding wire 292 is near the end of catheter 18 ... determine when occluding ball 290 is approaching seat 272”, col. 13 line 3 – col. 14 line 3).
Mottola does not expressly disclose that the interactive features are included along the length of the guidewire.
However, Bagaoisan directed to catheter systems with a tip indication mechanism discloses a guidewire (transport member 702/802, figs. 7A-8B, “guidewire”, para. [0044]) including interactive features along its length (detents 703/803, figs. 7A-8B, “803 disposed along the length ... 802 ... tactile feedback ... information on the state of the distal tip”, para. [0129-0130]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola such that the interactive features are included along the length of the guidewire, in view of the teachings of Bagaoisan, as this would aid in conveying information on the state of the distal tip through tactile feedback when advancing and retracting the guidewire.
Regarding claim 4, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 1, wherein the guidewire moves through a through hole of the rigid member (as seen in fig. 15).
Regarding claim 9, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 1, wherein the interactive features of the guidewire include differences in guidewire diameter, surface features, surface characteristics, composition, construction, or some combination thereof (continuously encircling ridge 295 & continuously encircling groove 296, figs. 13-15, “diameters ... D4 ... D3”, col. 12 lines 56-col. 13 line 17).
Regarding claim 10, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 9, wherein the guidewire diameter changes from one of a larger diameter or a smaller diameter to the other of the larger diameter or the smaller diameter to indicate the status of the guidewire with respect to the patient or the medical device (D4 D3, as seen in fig. 14, “diameter”, col. 12 lines 56-col. 13 line 17).
Regarding claim 14, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 9, wherein the guidewire construction changes from one of a bare-wire portion, a round-wound construction, a ground-wound construction, or a flat-wound potion of the guidewire (cylindrical portion 287 & sloped tapered portion 288, as seen in fig. 15) to another of the bare-wire portion, the round-wound construction, the ground-wound construction, or the flat-wound potion of the guidewire (coiled spring wire 292, as seen in fig. 15) to indicate the status of the guidewire with respect to the patient or the medical device (cylindrical portion 287 & sloped tapered portion 288 & coiled spring wire 292, as seen in fig. 15; “guide wire or other wire without an occluding ball can be used”; “provide sensing means ... tactually feel”, col. 4 lines 53-67 & col. 13 lines 3-8).
Regarding claim 15, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 1, wherein the medical device is a catheter assembly (Abstract, figs. 15).
Regarding claim 17, Mottola discloses using a guidewire-containing medical device with a tactile-feedback system (Abstract, col. 4 lines 13-64 & col. 12 lines 45-55, figs. 1 & 14-15), comprising: obtaining the medical device (“infusion catheter system is provided”, col. 2 lines 55-58, , figs. 1 & 14-15), the tactile-feedback system (Abstract, col. 4 lines 13-64 & col. 12 lines 45-55, figs. 1 & 14-15) including: a guidewire (occluding wire 22, figs. 14-15, “guide wire”, col. 4 lines 53-64 & col. 12 lines 45-55) including interactive features (spring wire 292 forming ridge 295 and groove 296 , figs. 14-15, “ridges projecting therefrom”, col. 4 lines 53-64 & col. 13 line 63 – col. 14 line 3); a rigid member (sensing ridge 276, fig. 13, “nylon ... shore 70D”, col. 11 lines 30-43 & col. 13 lines 35-62) in vibratory communication with a portion (proximal end 252, figs. 7 & 12-15) of the medical device (figs. 7 & 12-15, “transmit vibrations along the occluding wire 22 when occluding wire 22 is advanced within the lumen of infusion catheter 18”, col. 4 lines 13-64 & col. 13 lines 25 – col. 14 line 3), the interactive features of the guidewire interacting with the rigid member (“292 interact ... 276 ... rubbing ... ridges projecting therefrom”, col. 13 lines 25 – col. 14 line 3, fig. 15) to produce user-perceptible vibrations in the medical device as the guidewire moves against the rigid member (“tactually feel these vibrations ... transmit vibrations along occluding wire 22 ... advanced”, col. 13 lines 25 – col. 14 line 3); and advancing the guidewire out of the medical device or retracting the guidewire into the medical device (“occluding wire is advanced”, col. 13 line 3 – col. 14 line 3, figs. 13-15), thereby providing tactile feedback to a user of the medical device indicating a status of the guidewire with respect to a patient or the medical device (“actually feel when the occluding wire 292 is near the end of catheter 18 ... determine when occluding ball 290 is approaching seat 272”, col. 13 line 3 – col. 14 line 3).
Mottola further discloses that the sensing ridge could be placed on a variety of different types and styles of catheters to enable a surgeon to tactually feel the relative position of a wire positioned within the catheter (col. 3 lines 38-46).
Mottola does not expressly disclose a method of using the guidewire-containing medical device with a tactile-feedback system, that the interactive features are included along the length of the guidewire, a handholdable portion of the medical device, and producing user-perceptible vibrations in the handholdable portion of the medical device as the guidewire moves against the rigid member
However, Bagaoisan directed to catheter systems with a tip indication mechanism discloses a method of using the system (“methods of use for said systems”; “method is provided for using the device ... access and/or treat”, para. [0002, 0050]), a guidewire (transport member 702/802, figs. 7A-8B, “guidewire”, para. [0044]) including interactive features along its length (detents 703/803, figs. 7A-8B, “803 disposed along the length ... 802 ... tactile feedback ... information on the state of the distal tip”, para. [0129-0130]), a handholdable portion of the medical device (cannula hub 104/704/806, figs. 7A-8B, “hub 104 serves as a handle”, para. [0116, 0125, 0129]), and producing user-perceptible vibrations in the handholdable portion of the medical device as the guidewire moves against the member (“detents 703 engage the frictional member 706 ... tactile indication ... provide tactile feedback conveying information on the state of the distal tip of the transport member”, para. [0129-0130]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola to perform a method of using the guidewire-containing medical device with a tactile-feedback system, including the interactive features along the length of the guidewire, and producing user-perceptible vibrations in the handholdable portion of the medical device as the guidewire moves against the rigid member, in view of the teachings of Bagaoisan, as this would aid in accessing and/or treating body lumens and would aid in conveying information on the state of the distal tip through tactile feedback when advancing and retracting the guidewire.
Regarding claim 21, Mottola, as modified by Bagaoisan hereinabove, discloses the method of claim 17, wherein the interactive feature of the guidewire include differences in guidewire diameter, surface features, surface characteristics, composition, construction, or some combination thereof (continuously encircling ridge 295 & continuously encircling groove 296, figs. 13-15, “diameters ... D4 ... D3”, col. 12 lines 56-col. 13 line 17).
Claims 2, 5-7, 16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mottala in view of Bagaoisan, as applied to claims 1 and 17 above, and further in view of Ornelas Vargas (US 20180126126 A1).
Regarding claim 2, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 1.
Mottola recognizes that the sensing ridge 276 does not need to be annular but could comprise one or more fingers inwardly projecting from the surface (col. 13 lines 50-62).
Mottola, as modified by Bagaoisan hereinabove, does not disclose wherein the guidewire moves over the rigid member, the guidewire being between the rigid member and the user of the medical device from a perspective of the user looking down onto the medical device.
However, Ornelas Vargas directed to the single-handed insertion of a guidewire (para. [0004]) discloses a guidewire (guidewire 60/360, figs. 4 & 18) and a rigid member (protrusion 65/365, figs. 4 & 18, para. [0055]), wherein the guidewire moves over the rigid member (“over which guidewire 60 passes”, para. [0055], as seen in figs. 4 & 18), the guidewire being between the rigid member and the user of the medical device from a perspective of the user looking down onto the medical device (as seen in figs. 1 & 4 & 18, para. [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola, as modified by Bagaoisan hereinabove, such that the guidewire moves over the rigid member, the guidewire being between the rigid member and the user of the medical device from a perspective of the user looking down onto the medical device, in view of the teachings of Ornelas Vargas, as this would aid in enabling a user to advance the guidewire with one hand while providing/receiving tactile feedback by incorporating the housing having the protrusion of Ornelas Vargas into the system of Mottola.
Regarding claim 5, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 1. Mottola recognizes that sensing ridge 276 need not be positioned at tip opening 278 but could be positioned at one or more alternative locations along the length of catheter 18. (col. 13 lines 50-62).
Mottola, as modified by Bagaoisan hereinabove, does not disclose wherein the rigid member is a metal insert disposed in a housing of the medical device or a structural component associated with the housing.
However, Ornelas Vargas directed to the single-handed insertion of a guidewire (para. [0004]) discloses a guidewire (guidewire 60, fig. 4), a rigid member (protrusion 65, fig. 4, para. [0055]), and a housing of the medical device (housing 20, figs. 1 & 4, “guidewire housing 62 integral part of main housing 20”, para. [0054]), wherein the rigid member is a structural component associated with the housing (as seen in figs. 1 & 4, “guidewire housing 62 integral part of main housing 20 ... guidewire feed region 64 includes protrusion 65”, para. [0054-0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola, as modified by Bagaoisan hereinabove, such that the rigid member is a metal insert disposed in a housing of the medical device or a structural component associated with the housing, in view of the teachings of Ornelas Vargas, as this would aid in enabling a user to advance the guidewire with one hand while providing/receiving tactile feedback by incorporating the housing having the protrusion of Ornelas Vargas into the system of Mottola.
Regarding claim 6, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 1. Mottola recognizes that the sensing ridge 276 does not need to be annular but could comprise one or more fingers inwardly projecting from the surface (col. 13 lines 50-62).
Mottola, as modified by Bagaoisan hereinabove, does not disclose wherein the rigid member is a metal rod or plate.
However, Ornelas Vargas directed to the single-handed insertion of a guidewire (para. [0004]) discloses a guidewire (guidewire 60, fig. 4) and a rigid member (protrusion 65, fig. 4, para. [0055]), wherein the rigid member is a metal rod or plate (“raised plate”, para. [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola, as modified by Bagaoisan hereinabove, such that the rigid member is a metal rod or plate, in view of the teachings of Ornelas Vargas, as such a modification would have been merely a substitution of the sensing ridge of Mottola for the protrusion/raised plate of Ornelas Vargas to provide tactile feedback to the clinician while advancing or retracting the guidewire.
Regarding claim 7, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 1. Mottola, as modified by Bagaoisan hereinabove, does not expressly disclose wherein the status of the guidewire with respect to the patient is a depth to which the guidewire is inserted into the patient.
However, Ornelas Vargas directed to the single-handed insertion of a guidewire (para. [0004]) discloses a guidewire (guidewire 60, fig. 4) and a rigid member (protrusion 65, fig. 4, para. [0055]), wherein the status of the guidewire with respect to the patient is a depth to which the guidewire is inserted into the patient (“markers on guidewire 60 to indicate the length of guidewire 60 that has been inserted into the patient” para. [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola, as modified by Bagaoisan hereinabove, such that the status of the guidewire with respect to the patient is a depth to which the guidewire is inserted into the patient, in view of the teachings of Ornelas Vargas, as this would aid in indicating the length of the guidewire that has been inserted into the patient.
Regarding claim 16, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 1. Mottola further discloses that it should be understood that, e.g., guide wires with tactual feel for use with other catheters, wherein the occluding ball is omitted as being unnecessary and/or incompatible, are within the scope of the present invention (col. 12 lines 51-55). Mottola, as modified by Bagaoisan hereinabove, does not disclose wherein the medical device is a guidewire-management device.
However, Ornelas Vargas directed to the single-handed insertion of a guidewire (Abstract, para. [0004]) discloses wherein the medical device is a guidewire-management device (main housing 20 integrated with guidewire housing 62 & guidewire feed region 64, fig. 4, para. [0054-0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola, as modified by Bagaoisan hereinabove, such that the medical device is a guidewire-management device, in view of the teachings of Ornelas Vargas, as this would aid in enabling a user to advance the guidewire with one hand while providing/receiving tactile feedback by incorporating the housing having the guidewire housing and guidewire feed region of Ornelas Vargas into the system of Mottola.
Regarding claim 18, Mottola, as modified by Bagaoisan hereinabove, discloses the method of claim 17. Mottola, as modified by Bagaoisan hereinabove, does not expressly disclose wherein advancing the guidewire out of the medical device or retracting the guidewire into the medical device moves the guidewire over the rigid member, the guidewire being between the rigid member and the user of the medical device from a perspective of the user looking down onto the medical device.
However, Ornelas Vargas directed to the single-handed insertion of a guidewire (para. [0004]) discloses a guidewire (guidewire 60, fig. 4) and a rigid member (protrusion 65, fig. 4, para. [0055]), wherein advancing the guidewire out of the medical device or retracting the guidewire into the medical device moves the guidewire over the rigid member (“over which guidewire 60 passes ... advance guidewire ... retracted ... 65 can serve to provide tactile feedback”, para. [0055]), the guidewire being between the rigid member and the user of the medical device from a perspective of the user looking down onto the medical device (as seen in figs. 1& 4, para. [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola, as modified by Bagaoisan hereinabove, such that advancing the guidewire out of the medical device or retracting the guidewire into the medical device moves the guidewire over the rigid member, the guidewire being between the rigid member and the user of the medical device from a perspective of the user looking down onto the medical device, in view of the teachings of Ornelas Vargas, as this would aid in enabling a user to advance the guidewire with one hand while providing/receiving tactile feedback by incorporating the housing having the protrusion of Ornelas Vargas into the system of Mottola.
Regarding claim 19, Mottola, as modified by Bagaoisan hereinabove, discloses the method of claim 17.
Mottola further discloses that the sensing ridge could be placed on a variety of different types and styles of catheters to enable a surgeon to tactually feel the relative position of a wire positioned within the catheter (col. 3 lines 38-46).
Mottola, as modified by Bagaoisan hereinabove, does not expressly disclose wherein the rigid member is a metal rod or plate disposed in a housing of the medical device or a structural component associated with the housing.
However, Ornelas Vargas directed to the single-handed insertion of a guidewire (para. [0004]) discloses a guidewire (guidewire 60, fig. 4) and a rigid member (protrusion 65, fig. 4, para. [0055]), wherein the rigid member is a metal rod or plate disposed in a housing of the medical device or a structural component associated with the housing (“guidewire feed region 64 includes protrusion 65 ... main housing 20 ... raised plate”, para. [0065], as seen in fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola, as modified by Bagaoisan hereinabove, such that the rigid member is a metal rod or plate disposed in a housing of the medical device or a structural component associated with the housing, in view of the teachings of Ornelas Vargas, as this would aid in assisting in the gripping of guidewire to increase the efficiency of advancing and retracting the guidewire and providing tactile feedback to the clinician by incorporating the guidewire housing including the guidewire feed region and protrusion/plate of Bagaoisan into the catheter system of Mottola.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Mottala in view of Bagaoisan, as applied to claim 1 above, and further in view of Stone (US 20190282788 A1).
Regarding claim 3, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 1.
Mottola recognizes that the sensing ridge 276 does not need to be annular but could comprise one or more fingers inwardly projecting from the surface (col. 13 lines 50-62).
Mottola, as modified by Bagaoisan hereinabove, does not expressly disclose wherein the guidewire moves under the rigid member, the rigid member being between the guidewire and the user of the medical device from a perspective of the user looking down onto the medical device.
However, Stone directed to a device for one-handed insertion of a guidewire discloses that the guidewire (guidewire 12, as seen in figs. 1 & 22) moves under the rigid member (medial ridge 46, figs. 1 & 22), the rigid member (medial ridge 46, figs. 1 & 22) being between the guidewire and the user of the medical device from a perspective of the user looking down onto the medical device (as seen in figs. 1 & 22, “downwardly facing wire feed surfaces ... thumb engages the wire”; “12 ... forward or rearward movement across medial ridge ... sense the degree or amount of resistance”, para. [0004, 0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola, as modified by Bagaoisan hereinabove, such that the guidewire moves under the rigid member, the rigid member being between the guidewire and the user of the medical device from a perspective of the user looking down onto the medical device, in view of the teachings of Stone, as such a modification would have been merely a substitution of the sensing ridge of Mottola for the medial ridge of Stone and incorporating the wire guide feed module having the medial ridge into the catheter system of Mottola such that the operator is able to accurately sense the degree or amount of resistance guidewire encounters as it is being advanced.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mottala in view of Bagaoisan, as applied to claim 1 above, and further in view of Balkovec (US 20230309929 A1).
Regarding claim 8, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 1. Mottola, as modified by Bagaoisan hereinabove, does not expressly disclose wherein the status of the guidewire with respect to the medical device is whether a distal tip of the guidewire is within the medical device or outside the medical device.
However, Balkovec directed to elongated guidewire assembly having a tactile portion 810 (figs. 8A-8C) discloses wherein the status of the guidewire with respect to the medical device is whether a distal tip of the guidewire is within the medical device or outside the medical device (“the tactile portion 810 becomes exposed (that is, positioned exteriorly from the elongated introducer assembly 100) after the length of the distal segment 205 of the elongated guidewire assembly 200 has been extended away from the interior of the elongated introducer assembly 100 ... provide tactile feedback”, para. [0083-0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola, as modified by Bagaoisan hereinabove, such that the status of the guidewire with respect to the medical device is whether a distal tip of the guidewire is within the medical device or outside the medical device, in view of the teachings of Balkovec, as this would aid in providing tactile feedback indicating that the elongated guidewire assembly has reached an optimal amount of protrusion of the distal segment from the distal tip of the elongated introducer assembly.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Mottala in view of Bagaoisan, as applied to claim 9 above, and further in view of Dacanay (US 20200360669 A1).
Regarding claim 11, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 9. Mottola, as modified by Bagaoisan hereinabove, does not expressly disclose wherein the guidewire surface features change from one of a presence or a lack of the guidewire surface features to the other of the presence or the lack of the guidewire surface features to indicate the status of the guidewire with respect to the patient or the medical device.
However, Dacanay directed to safety guidewires that provide a tactile and/or a visual indicator of insertion length discloses wherein the guidewire surface features change from one of a presence or a lack of the guidewire surface features (distal end 72 shown without the coating 78, fig. 6) to the other of the presence or the lack of the guidewire surface features (proximal end 74 with textured coating 78, as seen in fig. 6) to indicate the status of the guidewire with respect to the patient or the medical device (“textured coating 78 on a portion of its length ... provide ... tactile indicator of sufficient insertion length into the patient”, para. [0032, 0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola, as modified by Bagaoisan hereinabove, such that the guidewire surface features change from one of a presence or a lack of the guidewire surface features to the other of the presence or the lack of the guidewire surface features to indicate the status of the guidewire with respect to the patient or the medical device, in view of the teachings of Dacanay, as this would aid in providing a user with a tactile indicator of sufficient insertion length into the patient and thus prevent over-insertion thereof.
Regarding claim 12, Mottola, as modified by Bagaoisan and Dacanay hereinabove, discloses the tactile-feedback system of claim 11, wherein the guidewire surface features are ridges, grooves, or some combination thereof (continuously encircling ridge 295 & continuously encircling groove 296, figs. 14-15).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Mottala in view of Bagaoisan, as applied to claim 9 above, and further in view of DiCicco (US 20230241349 A1).
Regarding claim 13, Mottola, as modified by Bagaoisan hereinabove, discloses the tactile-feedback system of claim 9. Mottola, as modified by Bagaoisan hereinabove, does not expressly disclose wherein the guidewire surface characteristics include surface roughness that changes from one degree of the surface roughness to another degree of the surface roughness to indicate the status of the guidewire with respect to the patient or the medical device.
However, DiCicco directed to an apparatus for use with an elongated medical device configured to be tacitly contacted by a user discloses an elongated guidewire-conveyance assembly 102 having a tactile feature 110 (fig. 4) wherein the surface characteristics (110 including sections 224 & 226, fig. 4) include surface roughness that changes from one degree of the surface roughness (smooth tactile lumen sections 224, fig. 4) to another degree of the surface roughness (rough tactile lumen section 226, fig. 4) (“tactile feature 110 includes (preferably) sections of varying surface roughness”, para. [0033]) to indicate the status of the guidewire with respect to the patient or the medical device (“tactile feature 110 is configured to provide tactile feedback to the user of the guidewire distal tip section 904 ... when the guidewire distal tip section 904 has reached the tactile feature 110 during urged movement”; “110 ... convey intended information to the user”, para. [0024, 0032, 0042]). DiCicco further discloses that the tactile feature 110 may be located at the guidewire distal tip section 904 and/or at the proximal section of the elongated guidewire assembly 902 (para. [0027, 0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola, as modified by Bagaoisan hereinabove, such that the guidewire surface characteristics include surface roughness that changes from one degree of the surface roughness to another degree of the surface roughness to indicate the status of the guidewire with respect to the patient or the medical device, in view of the teachings of DiCicco, as such a modification would have been merely a substitution of the ridges and grooves of Mottola for the tactile features including smooth and rough sections of DiCicco to convey information of the distal tip to the user through tactile feedback.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Mottala in view of Bagaoisan and Ornelas Vargas, as applied to claim 19 above, further in view of Ornelas Vargas, and further in view of Burkholz (US 20210290906 A1).
Regarding claim 20, Mottola, as modified by Bagaoisan hereinabove, discloses the method of claim 19.
Mottola, as modified by Bagaoisan hereinabove, does not expressly disclose wherein the status of the guidewire with respect to the patient is a depth to which the guidewire is inserted into the patient.
However, Ornelas Vargas directed to the single-handed insertion of a guidewire (para. [0004]) discloses a guidewire (guidewire 60, fig. 4) and a rigid member (protrusion 65, fig. 4, para. [0055]), wherein the status of the guidewire with respect to the patient is a depth to which the guidewire is inserted into the patient (“markers on guidewire 60 to indicate the length of guidewire 60 that has been inserted into the patient” para. [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola, as modified by Bagaoisan hereinabove, such that the status of the guidewire with respect to the patient is a depth to which the guidewire is inserted into the patient, in view of the teachings of Ornelas Vargas, as this would aid in indicating the length of the guidewire that has been inserted into the patient.
Mottola, as modified by Bagaoisan and Ornelas Vargas hereinabove, does not expressly disclose that the status of the guidewire with respect to the medical device is whether a distal tip of the guidewire is within the medical device or outside the medical device.
However, Burkholz directed to an extension set may including a patency instrument disposed within the tube, the patency instrument including a guidewire (Abstract, para. [0006, 0028]) discloses wherein the status of the guidewire with respect to the medical device is whether a distal tip of the guidewire is within the medical device or outside the medical device (“patency instrument 26 between a retracted position and an advanced position”, “tactile elements ... provide user feedback regarding a position of the patency instrument 26 with respect to the IV device”, para. [0030, 0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mottola, as modified by Bagaoisan and Ornelas Vargas hereinabove, such that the status of the guidewire with respect to the medical device is whether a distal tip of the guidewire is within the medical device or outside the medical device, in view of the teachings of Burkholz, as this would aid in providing user feedback regarding a retracted and advanced position of the patency instrument/guidewire with respect to the IV device/tube/catheter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Ornelas Vargasus (20170296792 A1) directed to a single-handed insertion of a guidewire, see figs. 4 & 8; Brown (US 20210016059 A1) directed to reducing or preventing unintentional advancement of guidewires during procedures such a central venous catheterization, see figs. 4A-B; Gottleib (US 20200114129 A1) directed to a guidewire configured to reduce the incidence of medical accidents when using guidewires, see figs. 16A-17 & 19B.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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