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 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 12 recites “a steerable sheath”. It is unclear if the recited “steerable sheath” is the same or a different sheath than the previously recited “sheath” in claim 1 from which claim 12 depends. For examination purposes the “steerable sheath” is interpreted as a different sheath than the “sheath” of claim 1.
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, 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]).
Syed does not explicitly disclose an anti-inflation lock mechanism to prevent improper inflation of a balloon. 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). 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 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 is configured to be positioned on a balloon luer that blocks passage of fluid to prevent the balloon from inflations ([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, 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 1; yet, is silent regarding further comprising a self-centering mechanism comprising a plurality of wires placed inside a steerable sheath configured to be triggered in a handle when 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
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.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799