DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 5/12/26. The claims 1-11 are pending. The claims 1, 6, 9, and 11 are amended.
Response to Arguments
Applicant’s arguments, filed 5/12/26 with respect to the rejections of claims 1, 4-10 under 35 U.S.C. 103 as being unpatentable over Syed (WO2022/072509) in view Ramzipoor (US2010/0185270) have been fully considered but the arguments are not persuasive. Applicant argues, the amendment “an anti-inflation lock mechanism positioned on a balloon line of the balloon, the anti-inflation lock mechanism configured to block passage of fluid through the balloon line to prevent improper inflation of the balloon when the balloon is positioned inside the sheath” overcomes the prior rejection. Examiner disagrees, as addressed in the rejection below. Applicant states Ramzipoor only teaches a generic stopcock that is part of an “inflation valve assembly 26” and does not teach or suggest an anti-inflation lock mechanism that is positioned on a balloon line of the balloon. The claim recites the anti-inflation lock mechanism as being “configured to block passage of fluid through the balloon line to prevent improper inflation of the balloon when the balloon is positioned inside the sheath” where the claim only functionally recites the condition of the balloon inflation being prevented when the balloon is inside the sheath. Where the modified invention of Syed with Ramzipoor teaches this functionality by the stopcock (anti-inflation lock mechanism) being able to be controlled by an operator, therefore could be in a closed configuration when the balloon is inside the sheath (see [0014] of Ramzipoor). The claim does not require any structural feature for coupling between the anti-inflation lock mechanism and the sheath, where the anti-inflation lock mechanism was interpreted under 35 U.S.C. 112(f) as “a safety device inserted on the balloon line/luer 104 that blocks the passage of fluid and does not allow balloon inflations” and equivalents thereof. Ramzipoors stopcock, is operable between open and closed configurations on the inflation line (see [0046]) and is a mechanism that blocks fluid passage through the balloon line (closed configuration) and prevents improper inflation whenever the operator closes it; therefore, meeting the 112(f) interpretation. Syed as modified by Ramzipoor would have the delivery system in which the balloon is initially positioned inside the sheath during navigation, the operator would close the stopcock to prevent accidental inflation while the balloon is sheathed, in the same manner as claimed.
Applicant has not defined any structural distinction between the “generic open/closed stopcock” of Ramzipoor and the claimed “anti-inflation lock mechanism” other than the purpose and positioning as defined in the specification. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was “for mixing flowing developer material” and the body of the claim recited “means for mixing ..., said mixing means being stationary and completely submerged in the developer material.” The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.). See MPEP 2173.
Applicant further argues that Ramzipoor does not teach the stopcock being positioned on a balloon line of the balloon. Ramzipoor explicitly discloses in paragraph [0046] that the inflation valve assembly 26 which includes the stopcock is connected to the catheter’s inflation pathway (balloon line). The stopcock is on the inflation line extending from the balloon which is the same structure as the balloon line of the balloon as recited in the claim. Applicant has not identified any structural difference between the inflation line of Ramzipoor and the balloon line of the balloon in the claim.
Applicant further argues, the Examiner has not articulated why a skilled artisan would configure the anti-inflation lock to be specifically positioned on the balloon line and to operate when the balloon is positioned inside the sheath, as opposed to merely providing a generic stopcock somewhere along an inflation pathway. The problem to be addressed of preventing accidental inflation while a balloon is inside of a delivery sheath would be known to a person of ordinary skill in the art familiar with TAVR delivery systems, since the balloon in Syed delivery system is positioned inside a sheath during insertion through the sheath ([0074]) and not intended to expanded until after the balloon is released from the sheath, since accidental balloon inflation while sheathed would cause significant damage and harm to the patient and a stopcock or anti-inflation lock on the balloon inflation line is a solution to prevent inadvertent inflation.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 recites “configured to be positioned on a balloon line/luer” should be changed to recite “configured to be positioned on a balloon line”. 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:
“anti-inflation lock mechanism” in claim 1. From the specification paragraph [0020], the “anti-inflation lock mechanism” are interpreted as “a safety device inserted on the balloon line/luer 104 that blocks the passage of fluid and does not allow balloon inflations” and equivalents thereof.
“self-centering mechanism” in claim 2. From the specification paragraph [0023], the “self-centering mechanism” is interpreted as being “composed of wires 401 inside the steerable sheath that is triggered in the handle when the valve is positioned in the aortic annulus” and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
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 of this title, 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.
Claims 1 and 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Syed (WO2022/072509) in view Ramzipoor (US2010/0185270).
Regarding claim 1, Syed discloses a delivery system for a balloon-expandable transcatheter valve implantation (Abstract, [0073]), comprising:
a sheath (sheath 104) comprising a flared portion (valve sheath 138, where the valve sheath 138 has a larger diameter than the outer diameter of the shaft 104 and therefore is interpreted as being “flared”, [081]) positioned at a tip of the sheath to partially sheathe a transcatheter valve during blood vessel navigation ([078]); and
a reinforced balloon catheter shaft (balloon shaft 106) configured to prevent the balloon from kinking within a blood vessel (leg portion 122 is interpreted as reinforcement for the shaft, and have a shore hardness of 75D which would prevent kinking, [066]), the reinforced balloon catheter shaft supporting the balloon when the transcatheter valve is loaded on the balloon (valve is crimped around balloon for insertion, [074]).
Syed does not explicitly disclose an anti-inflation lock mechanism positioned on a balloon line of the balloon, the anti-inflation lock mechanism configured to block passage of fluid through the balloon line to prevent improper inflation of the balloon when the balloon is positioned inside the sheath. Ramzipoor teaches a catheter with a distal balloon that is guided to a treatment site ([0002]). The catheter having an inflation valve assembly 26 having a stopcock that is operable between a closed and open configuration ([0046]) (where the stopcock has been interpreted as the “the anti-inflation lock mechanism” interpreted under 35 U.S.C. 112(f) by being a structure that can block the passage of fluid). Where the stopcock is in communication with an inflation line to the balloon (balloon line of the balloon) ([0014]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the delivery system of Syed to include an anti-inflation lock mechanism in communication with a balloon line to the balloon as taught by Ramzipoor in order to controllably inflate the balloon (Ramzipoor in paragraph [0018] states describes opening the stop to partially inflate the balloon, and closing after which would prevent inflation).
Regarding claim 4, Syed/Ramzipoor makes obvious the system of claim 1, Syed further discloses wherein the sheath is configured to house the balloon during an implantation procedure (the sheath 138 covers the balloon of the balloon shaft 106, [079]).
Regarding claim 5, Syed/Ramzipoor makes obvious the system of claim 1, the modified invention discloses wherein the anti-inflation lock mechanism is configured to prevent an operator from inflating or expanding the balloon when the balloon is not completely freed up (Ramzipoor teaches the inflation of the balloon being controllable by a stopcock in paragraph [0046], where the stopcock is capable of preventing an operator from inflating the balloon when the balloon is not freed up by having the stopcock in the closed position).
Regarding claim 6, Syed/Ramzipoor makes obvious the system of claim 1, Ramzipoor further teaches wherein the anti-inflation lock mechanism is configured to be positioned on a balloon line that blocks passage of fluid to prevent the balloon from inflating ([0016] of Ramzipoor).
Regarding claim 7, Syed/Ramzipoor makes obvious the system of claim 1, Syed further discloses wherein the sheath is steerable ([085]) and configured to house a balloon catheter therein (the sheath 138 covers the balloon of the balloon shaft 106, [079]).
Regarding claim 8, Syed/Ramzipoor makes obvious the system of claim 7, Syed further discloses wherein the steerable sheath is configured to guide a tip of the balloon ([085]) and support the transcatheter valve ([070]).
Regarding claim 9, Syed/Ramzipoor makes obvious the system of claim 7, Syed further discloses further comprising a handle is connected to the balloon catheter and the steerable sheath to allow an operator to flex and move tip of the balloon (handle is intended to flex and guide the balloon the desired site, [085]).
Regarding claim 10, Syed/Ramzipoor makes obvious the system of claim 9, Syed further discloses wherein an extension of the balloon catheter (proximal end of tubular portion 197, which extends from balloon catheter 106, [0117], [0118]) crosses inside the handle and ends in a guidewire port (portion 197 extends inside the handle 102 and the guidewire is inserted through handle via 197 and therefore the opening of 197 is interpreted as a guidewire port, [0117], see Fig. 12).
Claims 2, 3, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Syed (WO2022/072509) in view Ramzipoor (US2010/0185270) as applied to claim 1, and further in view of Ryan (US2008/0228254).
Regarding claims 2 and 3, Syed/Ramzipoor makes obvious the system of claim 1; yet, is silent regarding further comprising a self-centering mechanism configured to center the balloon within an aortic annulus before the implantation procedure, the self-centering mechanism comprises a plurality of wires configured to be pushed outside the sheath to create a cage that accommodates the annulus and forces the balloon to be in a center of the annulus to allow for a central balloon expansion. Ryan teaches a system 302 for deploying a stent, where the system includes petal structures 306 (interpreted as the plurality of wires of self-centering mechanism) ([0098]). The petal structures 306 provide a centering function within an annulus to deploy the stent ([0098]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the system of Syed/Ramzipoor to include a self-centering mechanism as taught by Ryan in order to improve the delivery of the stent by ensuring the delivery device is centered before deploying the stent ([0098 of Ryan).
Regarding claim 11, Syed/Ramzipoor makes obvious the system of claim 7; yet, is silent regarding further comprising a self-centering mechanism comprising a plurality of wires placed inside the steerable sheath configured to be triggered by the handle when the transcatheter valve is positioned in an aortic annulus. Ryan teaches a system 302 (steering sheath) for deploying a stent, where the system includes petal structures 306 (interpreted as the plurality of wires of self-centering mechanism) ([0098]). The petal structures 306 provide a centering function within an annulus to deploy the stent ([0098]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the system of Syed/Ramzipoor to include a self-centering mechanism as taught by Ryan in order to improve the delivery of the stent by ensuring the delivery device is centered before deploying the stent ([0098 of Ryan). Where the sheath is interpreted as steerable by being guided to the target site and where the handle is capable of triggering the plurality of wires by actuating the sheath or another component.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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