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 .
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.
Response to Amendment
The amendment filed 09/07/2025 has been entered. Claims 1-11, 15-19, and 21 remain pending. Claims 12-14 and 20 have been cancelled. Claims 17-19 remain withdrawn from consideration.
Response to Arguments
Applicant's arguments filed 09/07/2025 have been fully considered but they are not persuasive.
Regarding Applicant's arguments that the amendment that specifies that the anchor driver is configured to advance the tissue anchor through the catheter and into the lumen vacated by the ultrasound tool renders the claims patentable over the prior art on record, the Examiner respectfully disagrees. Although the Examiner recognizes that there are advantages to performing the imaging before the anchoring, the newly added limitations are mainly functional, and given limited patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. The Applicant argues that the delivery catheter of Lashinski does not read on the newly amended claims, as “Lashinski teaches an ultrasound tool that is part of the delivery tool to which the implant is attached,” and that “modifying Iflah in view of Lashinski, as alleged in the Office Action, would result in, at most, an ultrasound transceiver as a component of the delivery system to which the implant is coupled and that is present at the implant during anchoring,” in which the Examiner disagrees as the ultrasound catheter 30 of Lashinski is advanced down an offset, non-central lumen of the delivery catheter (see paragraph [0110], meaning it could also be retracted through that same lumen), as well as it disclosed that it can be completely separate from the delivery catheter (see paragraph [0111]). Due to the above, the ultrasound catheter of Lashinski would be capable of vacating the respective site before the anchoring of the anchors into the tissue, and would therefore read upon the newly added functional limitations.
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 limitations use 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 limitations are: “contraction member” and an “adjustment mechanism” in Claim 16.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification discloses that the “contraction member” is a “line” or “wire” or “suture” (see paragraph [0167]). The specification discloses that "adjustment mechanism" is “rotatable spool” (see paragraph [0224]).
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170135816 A1 (hereafter --Lashinski--).
Regarding Claim 1, Lashinski discloses a system for use with a tissue of a subject, the system comprising: an implant (500) comprising a wall that surrounds a lumen (see annotated wall and lumen in Figure 30C below, see also paragraph [0146] denoting that the delivery tools can be used to delivery any implant, including implant 1, or even implant 500); a delivery tool (see delivery tool in Figure 28 below), the delivery tool comprising: a catheter (see annotated catheter 40 in Figure 22D below), transluminally advanceable to the tissue and having a distal part that includes a distal opening (see annotated distal part and opening in Figure 22D below), the implant configured to be delivered to the tissue via the catheter; an extracorporeal control assembly (see extracorporeal control assembly 400 in Figure 28 below): configured to advance at least a portion of the wall out of the distal opening (see implant advancing out the distal end of the steerable sheath 402, in which the catheter 40 in within as 270 is within 40 and is sticking out the distal end in Figure 28 below), and operably coupled to the distal part to steer the distal part to place the portion of the wall against a site of the tissue (see annotated steerable sheath 402 in Figure 28 below, see also paragraph [0121], the site disposed distally from the portion of the wall and opposite the distal opening; and an ultrasound tool: advanceable within the catheter (see paragraph [0109]), comprising an ultrasound transceiver at a distal end thereof (see paragraphs [0023] and [0109]), configured to: position the ultrasound transceiver in a position that is within the lumen of the implant (see ultrasound transceiver in lumen of the implant 10 in Figure 22D below, implant 10 being analogous to 500 as the delivery tools can delivery any implant embodiment) and facing the portion of the wall, and facilitate imaging of the site by transmitting ultrasound energy through the portion of the wall and into the site (see paragraph [0112] denoting that the ultrasound transducer remains centered in the lumen of the implant and is rotated to the wall to see each anchor through the wall); a tissue anchor (see annotated tissue anchor 516 in Figure 30C below); and an anchor driver configured to anchor the implant to the tissue by driving the tissue anchor through the portion of the wall and into the site (see annotated anchor driver components (402, 403, 406, and 408 in Figure 28 below, see also paragraph [0122], see catheter 270 in Figure 28, the ultrasound catheter that is analogous to ultrasound catheter 30 that is within catheter 40, see also paragraph [0121] denoting that the delivery system can be used to deliver any of the implants described in the specification).
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The limitation “subsequently vacate the lumen;” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the ultrasound catheter being able to enter the lumen through either the delivery catheter lumen or introduced secondarily through another entry side, such as through the aortic valve (see paragraphs [0110] and [0111]), the ultrasound catheter would be capable of vacating the lumen once the imaging of the lumen has commenced.
The limitation “advancing the tissue anchor through the catheter and into the vacated lumen to the implant” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the tissue anchors 516 being on the outer frame 512, and the outer frame being disclosed to cinched and compressed within the delivery catheter until deployment from said catheter (see paragraph [0130]), as well as that it is disclosed that the anchors 516 engage either the outer frame, inner frame, and can either be retracted or pre-anchored, as disclosed in Lashinski (see paragraph [0131]), as well as it is disclosed that the anchors can penetrate the tissue and can pull the valve annulus inwards towards the implant to reduce the circumference of the annulus to conform to the implant (see paragraph [0131]) the tissue anchor is capable of “being advanced through the catheter and into the vacated lumen to the implant”.
Regarding Claim 2, Lashinski discloses the system according to claim 1, wherein the catheter is configured to be transfemorally and transseptally advanceable to the tissue (see paragraph [0011]).
Regarding Claim 3, Lashinski discloses the system according to claim 1, wherein the distal part of the catheter is at least partly radiopaque (see paragraph [0114]).
Regarding Claim 4, Lashinski discloses the system according to claim 1, wherein the anchor driver is configured to advance the tissue anchor through the catheter to the implant while the implant is disposed at the tissue (see paragraph [0121] denoting that the anchor driver component 408 rotationally advances would anchor 20 of implant 10, analogous to anchors 516 in implant 500 in Figure 30C, into tissue).
Regarding Claim 5, Lashinski discloses the system according to claim 1, wherein: the ultrasound transceiver is configured to detect reflected ultrasound energy, the reflected ultrasound energy being a portion of the ultrasound energy that is transmitted by the ultrasound transceiver, and that is reflected from the site (see paragraph [0116] denoting that the ultrasound transducer takes a circumferential echo image, a process that involves transmitting and detecting, as the received reflected echoes are needed to create the image in all ultrasound transducers), and the ultrasound tool further comprises: an ultrasound controller comprising circuitry and a user interface (see paragraph [0116]), the ultrasound controller configured to facilitate analysis of the reflected ultrasound energy detected by the ultrasound transceiver, and a connector configured to relay, from the ultrasound transceiver to the ultrasound controller, data indicative of the reflected ultrasound energy detected by the ultrasound transceiver (see paragraph [0116] denoting that software of electronic controls can be used in connection with the transducers to cycle through the cross section images of the perimeter, which would be the data indicative of the detected echoes turned into images).
Regarding Claim 6, Lashinski discloses the system according to claim 5.
The limitation “wherein the reflected ultrasound energy is reflected from the site through the portion of the wall, and wherein the ultrasound transceiver is configured to detect the reflected ultrasound energy that is reflected from the site through the portion of the wall” is treated as functional language, that is given limited patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the ultrasound transducer being able to turn detected echo signals into images of the heart, it would be able to transmit and reflect ultrasonic energy from the site, through the implant, and back to the ultrasonic device.
Regarding Claim 7, Lashinski discloses the system according to claim 1, wherein the delivery tool further comprises an anchor channel, the anchor channel: defining a longitudinal cavity ending at a distal aperture, extending through the catheter such that a distal region of the anchor channel is disposed within the lumen, the distal region including the distal aperture, and being advanceable within the catheter and the lumen (see annotated anchor channel 303 in Figure 29 below located within catheter 270, see also catheter 270 within the lumen of the implant in Figure 28 above).
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Regarding Claim 8, Lashinski discloses the system according to claim 7, wherein the anchor channel is configured to extend through the catheter such that: the distal region of the anchor channel is disposed within the lumen, the distal region including the distal aperture (see annotated anchor channel 303 in Figure 29 above located within catheter 270, see also catheter 270 within the lumen of the implant in Figure 28 above), and the anchor channel facilitates positioning of the portion of the wall at the site (see paragraph [0116]).
Regarding Claim 15, Lashinski discloses the system according to claim 1, wherein the implant comprises an annuloplasty structure, the annuloplasty structure comprising a sleeve defined by the wall (see annotated structure and sleeve in Figure 30C above).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1, 7, 9-11, 15-16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180049875 A1 (hereafter --Iflah--), in further view of US 20170135816 A1 (hereafter --Lashinski--).
Regarding Claim 1, Iflah discloses a system (10) for use with a tissue of a subject, the system comprising: an implant (222) comprising a wall (253) that surrounds a lumen (see paragraph [0397], see also Figure 1 below); a delivery tool, the delivery tool comprising: a catheter (14), transluminally advanceable to the tissue and having a distal part that includes a distal opening (see annotated distal part and distal part in Figure 3E below), the implant configured to be delivered to the tissue via the catheter (see Figures 1 and 3E below); an extracorporeal control assembly (12): configured to advance at least a portion of the wall out of the distal opening (see Figure 1 bellow, see also paragraph [0437]), and operably coupled to the distal part to steer the distal part to place the portion of the wall against a site of the tissue (see paragraph [0400] denoting that the outer catheter 12 connected to the catheter 14 by surrounding it, is steerable by extracorporeal elements), the site disposed distally from the portion of the wall and opposite the distal opening (see annotated site in Figure 3E below); a tissue anchor (see anchor 32 in Figure 3E below); and an anchor driver configured to anchor the implant to the tissue by driving the tissue anchor through the portion of the wall and into the site (see annotated anchor driver 36 in Figure 3E below, see also paragraph [0411]).
The limitation “advancing the tissue anchor through the catheter and into the vacated lumen to the implant” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to anchors being delivered into the heart through the sleeve 26 and into the lumen, into the cardiac tissue where the implant is located (see paragraph [0405]), the tissue anchor is capable of “being advanced through the catheter and into the vacated lumen to the implant”.
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Iflah fails to disclose an ultrasound tool: advanceable within the catheter, comprising an ultrasound transceiver at a distal end thereof, configured to: position the ultrasound transceiver in a position that is within the lumen of the implant and facing the portion of the wall, and facilitate imaging of the site by transmitting ultrasound energy through the portion of the wall and into the site.
Lashinski discloses a system for use with a tissue of a subject, the system comprising: an implant (500) comprising a wall that surrounds a lumen (see annotated wall and lumen in Figure 30C below, see also paragraph [0146] denoting that the delivery tools can be used to delivery any implant, including implant 1, or even implant 500); a delivery tool (see delivery tool in Figure 28 below), the delivery tool comprising: a catheter (see annotated catheter 40 in Figure 22D below), transluminally advanceable to the tissue and having a distal part that includes a distal opening (see annotated distal part and opening in Figure 22D below), the implant configured to be delivered to the tissue via the catheter; an extracorporeal control assembly (see extracorporeal control assembly 400 in Figure 28 below): configured to advance at least a portion of the wall out of the distal opening (see implant advancing out the distal end of the steerable sheath 402, in which the catheter 40 in within as 270 is within 40 and is sticking out the distal end in Figure 28 below), and operably coupled to the distal part to steer the distal part to place the portion of the wall against a site of the tissue (see annotated steerable sheath 402 in Figure 28 below, see also paragraph [0121], the site disposed distally from the portion of the wall and opposite the distal opening; a tissue anchor (see annotated tissue anchor 516 in Figure 30C below); and an anchor driver configured to anchor the implant to the tissue by driving the tissue anchor through the portion of the wall and into the site (see annotated anchor driver components (402, 403, 406, and 408 in Figure 28 below, see also paragraph [0122], see catheter 270 in Figure 28, the ultrasound catheter that is analogous to ultrasound catheter 30 that is within catheter 40, see also paragraph [0121] denoting that the delivery system can be used to deliver any of the implants described in the specification). Lashinski teaches an ultrasound tool: advanceable within the catheter (see paragraph [0109]), comprising an ultrasound transceiver at a distal end thereof (see paragraphs [0023] and [0109]), configured to: position the ultrasound transceiver in a position that is within the lumen of the implant (see ultrasound transceiver in lumen of the implant 10 in Figure 22D below, implant 10 being analogous to 500 as the delivery tools can delivery any implant embodiment) and facing the portion of the wall, and facilitate imaging of the site by transmitting ultrasound energy through the portion of the wall and into the site (see paragraph [0112] denoting that the ultrasound transducer remains centered in the lumen of the implant and is rotated to the wall to see each anchor through the wall).
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Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention to further include an ultrasound transceiver at a distal end thereof, configured to: position the ultrasound transceiver in a position that is within the lumen of the implant and facing the portion of the wall, and facilitate imaging of the site by transmitting ultrasound energy through the portion of the wall and into the site , as by doing so would enable the tool to capture a circumferential echo image for properly positioning the implant in a plane above the heart valve and its leaflets, increasing visibility during implantation, as taught by Lashinski (see paragraph [0115]).
The limitation “subsequently vacate the lumen;” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the ultrasound catheter of Lashinski, and therefore of Iflah as modified, being able to enter the lumen through either the delivery catheter lumen or introduced secondarily through another entry side, such as through the aortic valve (see paragraphs [0110] and [0111]), the ultrasound catheter would be capable of vacating the lumen once the imaging of the lumen has commenced.
Regarding Claim 7, Iflah as modified discloses the system according to claim 1, wherein the delivery tool further comprises an anchor channel, the anchor channel: defining a longitudinal cavity ending at a distal aperture, extending through the catheter such that a distal region of the anchor channel is disposed within the lumen, the distal region including the distal aperture, and being advanceable within the catheter and the lumen (see annotated anchor channel 18 located within catheter 14, see also annotated distal aperture in Figures 1 and 3E above).
Regarding Claim 9, Iflah as modified discloses the system according to claim 7, wherein the anchor driver (36) is: advanceable, while coupled to the tissue anchor, through the longitudinal cavity to the implant, so as to advance the tissue anchor into the lumen of the implant (see paragraph [0410]), in a manner in which the tissue anchor reaches the portion of the wall, and removable from the longitudinal cavity, via a proximal opening of the catheter (see paragraphs [0410] and [0414]).
Regarding Claim 10, Iflah as modified discloses the system according to claim 9.
Iflah as modified fails to disclose wherein the ultrasound transceiver is: advanceable through the longitudinal cavity into the lumen of the implant such that the ultrasound transceiver is facing the portion of the wall, and removable from the longitudinal cavity, through the proximal opening of the catheter.
Lashinski teaches the ultrasound catheter that has an ultrasound transceiver attached therein advanceable through the lumen of the catheter (which is a longitudinal cavity) (see paragraph [0109]) and into the lumen of the implant such that the ultrasound transceiver is facing the portion of the wall, and removable from the longitudinal cavity, through the proximal opening of the catheter (see paragraph [0112] denoting that the ultrasound catheter comes out of the distal end of the catheter and extends into the lumen of the implant frame, where the catheter can be rotated to face the directions of the frame, see also Figure 28 below).
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Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention to have the ultrasound transceiver be advanceable through the longitudinal cavity into the lumen of the implant such that the ultrasound transceiver is facing the portion of the wall, and removable from the longitudinal cavity, through the proximal opening of the catheter, as by doing so would enable the operator, such as a surgeon or technician, to need to only rotate the ultrasound catheter to view each anchor and placement the of each anchor as taught by Lashinski (see paragraph [0112]).
Regarding Claim 11, Iflah as modified discloses the system according to claim 10, wherein the anchor driver is advanceable through the longitudinal cavity to the implant (see paragraph [0410]).
Iflah fails to disclose wherein the anchor driver is advanceable through the longitudinal cavity only while the ultrasound transceiver is not disposed through the longitudinal cavity.
The Instant Application does not disclose that the anchor driver being advanceable through the longitudinal cavity only while the ultrasound transceiver is not disposed through the longitudinal cavity solves any problem or is for any particular purpose, nor does it place criticality on the limitation (see paragraph [0010] denoting that the limitation is “optional” as it starts off with “optionally” before describing the limitation). It appears that Iflah’s delivery tool would perform equally well and function as intended with the anchor driver being advanceable through the longitudinal cavity while the ultrasound transceiver is disposed through the longitudinal cavity. Therefore, it would have been obvious to one having ordinary skill in the art to make the anchor driver be advanceable through the longitudinal cavity only while the ultrasound transceiver is not disposed through the longitudinal cavity, as an obvious matter of design choice within the skill of the art.
Regarding Claim 15, Lashinski discloses the system according to claim 1, wherein the implant comprises an annuloplasty structure, the annuloplasty structure comprising a sleeve defined by the wall (see annotated annuloplasty structure, sleeve, and wall in Figure 1 above, see also paragraph [0397]).
Regarding Claim 16, Lashinski discloses the system according to claim 15, wherein the annuloplasty structure further comprises a contraction member and an adjustment mechanism (as interpreted under 112f, see paragraph [0397] denoting that the contraction member can be a wire as aligned with the 112f interpretation explained above, see also paragraph [0398] denoting that the adjustment mechanism is a rotating structure (spool) as aligned with the 112f interpretation explained above, see also annotated adjustment member 40 in Figure 1 above, see also paragraph [0469]), wherein: the adjustment mechanism is configured to, when actuated, apply tension to the contraction member (see paragraph [0467]), and the contraction member is configured to adjust a length of the annuloplasty structure when the contraction member is tensioned by actuating the adjustment mechanism (see paragraph [0467]).
Lashinski discloses a system for use with a tissue of a subject, the system comprising: an implant (500) comprising a wall that surrounds a lumen (see annotated wall and lumen in Figure 30C below, see also paragraph [0146] denoting that the delivery tools can be used to delivery any implant, including implant 1, or even implant 500); a delivery tool (see delivery tool in Figure 28 below), the delivery tool comprising: a catheter (see annotated catheter 40 in Figure 22D below), transluminally advanceable to the tissue and having a distal part that includes a distal opening (see annotated distal part and opening in Figure 22D below), the implant configured to be delivered to the tissue via the catheter; an extracorporeal control assembly (see extracorporeal control assembly 400 in Figure 28 below): configured to advance at least a portion of the wall out of the distal opening (see implant advancing out the distal end of the steerable sheath 402, in which the catheter 40 in within as 270 is within 40 and is sticking out the distal end in Figure 28 below), and operably coupled to the distal part to steer the distal part to place the portion of the wall against a site of the tissue (see annotated steerable sheath 402 in Figure 28 below, see also paragraph [0121], the site disposed distally from the portion of the wall and opposite the distal opening; and an ultrasound tool: advanceable within the catheter (see paragraph [0109]), comprising an ultrasound transceiver at a distal end thereof (see paragraphs [0023] and [0109]), configured to: position the ultrasound transceiver in a position that is within the lumen of the implant (see ultrasound transceiver in lumen of the implant 10 in Figure 22D below, implant 10 being analogous to 500 as the delivery tools can delivery any implant embodiment) and facing the portion of the wall, and facilitate imaging of the site by transmitting ultrasound energy through the portion of the wall and into the site (see paragraph [0112] denoting that the ultrasound transducer remains centered in the lumen of the implant and is rotated to the wall to see each anchor through the wall); a tissue anchor (see annotated tissue anchor 516 in Figure 30C below); and an anchor driver configured to anchor the implant to the tissue by driving the tissue anchor through the portion of the wall and into the site (see annotated anchor driver components (402, 403, 406, and 408 in Figure 28 below, see also paragraph [0122], see catheter 270 in Figure 28, the ultrasound catheter that is analogous to ultrasound catheter 30 that is within catheter 40, see also paragraph [0121] denoting that the delivery system can be used to deliver any of the implants described in the specification).
Regarding Claim 21, Iflah discloses a system (10) for use with a tissue of a subject, the system comprising: an implant (222) comprising a wall (253) that surrounds a lumen (see paragraph [0397], see also Figure 1 below); multiple tissue anchors (32) (see paragraph [0405]); a delivery tool, the delivery tool comprising: a catheter (14), transluminally advanceable to the tissue and having a distal part that includes a distal opening (see annotated distal part and distal part in Figure 3E below), the implant configured to be delivered to the tissue via the catheter (see Figures 1 and 3E below); an extracorporeal control assembly (12): configured to advance at least a portion of the wall out of the distal opening (see Figure 1 bellow, see also paragraph [0437]), and operably coupled to the distal part to steer the distal part to place the portion of the wall against a site of the tissue (see paragraph [0400] denoting that the outer catheter 12 connected to the catheter 14 by surrounding it, is steerable by extracorporeal elements), and an anchor driver (see annotated anchor driver 36 in Figure 3E below, see also paragraph [0411]), wherein the delivery tool is configured to implant the implant at the tissue by, for each of the anchors in turn: placing a respective portion of the wall against a respective site of the tissue and while maintaining the respective portion of the wall against the respective site, using the anchor driver to advance the tissue anchor through the lumen and drive the tissue anchor through the respective portion of the wall and into the respective site (see annotated anchor driver 36 in Figure 3E below, see also paragraph [0411]), and subsequently, vacating the anchor driver from the lumen (see paragraph [0410]).
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Iflah fails to disclose an ultrasound tool: advanceable within the catheter, comprising an ultrasound transceiver at a distal tip thereof; positioning the ultrasound transceiver in a position that is within the lumen of the implant and facing the respective portion of the wall, facilitating imaging of the respective site by transmitting ultrasound energy from the ultrasound transceiver, distally along a longitudinal axis of the ultrasound tool and the catheter through the respective portion of the wall and into the respective site, subsequently, and while maintaining the respective portion of the wall against the respective site, vacating the ultrasound tool from the lumen, and subsequently, vacating the anchor driver from the lumen in readiness for reintroduction of the ultrasound transceiver into the lumen.
Lashinski teaches an ultrasound tool: advanceable within the catheter (see paragraph [0109]), comprising an ultrasound transceiver at a distal end thereof (see paragraphs [0023] and [0109]); positioning the ultrasound transceiver in a position that is within the lumen of the implant and facing the respective portion of the wall (see ultrasound transceiver in lumen of the implant 10 in Figure 22D below, implant 10 being analogous to 500 as the delivery tools can delivery any implant embodiment) and facilitate imaging of the site by transmitting ultrasound energy from the ultrasound transceiver, distally along a longitudinal axis of the ultrasound tool and the catheter through the respective portion of the wall and into the respective site (see paragraph [0112] denoting that the ultrasound transducer remains centered in the lumen of the implant and is rotated to the wall to see each anchor through the wall). The limitation “subsequently, and while maintaining the respective portion of the wall against the respective site, vacating the ultrasound tool from the lumen, and subsequently, vacating the anchor driver from the lumen in readiness for reintroduction of the ultrasound transceiver into the lumen”
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Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention to further include an ultrasound transceiver at a distal tip thereof; positioning the ultrasound transceiver in a position that is within the lumen of the implant and facing the respective portion of the wall, facilitating imaging of the respective site by transmitting ultrasound energy from the ultrasound transceiver, distally along a longitudinal axis of the ultrasound tool and the catheter through the respective portion of the wall and into the respective site, as by doing so would enable the tool to capture a circumferential echo image for properly positioning the implant in a plane above the heart valve and its leaflets, increasing visibility during implantation, as taught by Lashinski (see paragraph [0115]).
The limitation “subsequently, and while maintaining the respective portion of the wall against the respective site, vacating the ultrasound tool from the lumen” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the ultrasound catheter of Lashinski, and therefore of Iflah as modified, being able to enter the lumen through either the delivery catheter lumen or introduced secondarily through another entry side, such as through the aortic valve (see paragraphs [0110] and [0111]), the ultrasound catheter would be capable of vacating the lumen once the imaging of the lumen has commenced while maintaining the respective portion of the wall against the respective site.
The limitation “vacating the anchor driver from the lumen in readiness for reintroduction of the ultrasound transceiver into the lumen” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the anchor drivers of Iflah being disclosed to be removed from the lumen once the anchor is driven into the lumen (see paragraph [0410]), the anchor driver would be able to be vacated from the lumen in “readiness for reintroduction of the ultrasound transceiver into the lumen”, in anticipation for the introduction of the ultrasound transceiver of Iflah as modified by Lashinski, which is disclosed to be able to enter the lumen through either the delivery catheter lumen or introduced secondarily through another entry side, such as through the aortic valve (see paragraphs [0110] and [0111] of Lashinski).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774