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
Claim 19 objected to because of the following informalities: “each of the at least shapable elements” should read “each of the plurality of shapeable elements.”
Claim 20 objected to because of the following informalities: "prosthetic valves leaflets” should read “prosthetic valve leaflets”. Appropriate correction is required.
Claim 26 objected to because of the following informalities: .
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:
flexible carrying element in claim 1.
reinforcing expandable elements in claim 1.
injection device in claim 27.
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.
Claims 1, 3-5, 7-8, 10, 12, 15-16, 19-20, 26-27 and 30 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “highly” in claim 1 is a relative term which renders the claim indefinite. The term “highly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. When the supporting structure is no longer considered average compressibility has been rendered indefinite by the use of the term highly. Dependent claims 3-5, 7-8, 10, 12, 15-16, 19-20, 26-27 and 30 are likewise rejected.
The term “substantially” in claim 1 is a relative term which renders the claim indefinite. The term “substantial” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The degree of parallel the shapeable and reinforcing expandable elements are has been rendered indefinite by the use of the term substantially. Dependent claims 3-5, 7-8, 10, 12, 15-16, 19-20, 26-27 and 30 are likewise rejected.
The term “rapid” in claim 3 is a relative term which renders the claim indefinite. The term “rapid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The rate of endothelial growth has been rendered indefinite by use of the term rapid.
Claim 12 recites “at least one fluid being in the form of at least on . . . powder, or granules . . . “ Powder and granules are not considered a fluid. It is unclear if the filling requires a fluid or not.
Claim 26 recites “a filling material . . . being capable of . . . deploying the sterile prosthetic valve onto a native mitral valve.” It is unclear if deploying the prosthetic valve onto the native mitral valve is functional language of the filling material or the kit as a whole. Dependent claims 27 and 30 are likewise rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 10, 15-16 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bishop (US 2008/0208329 A1).
Regarding claim 1, a first embodiment of Bishop teaches a flexible carrying element (102, cuff, fig. 3B) defining an open cavity and being capable of accommodating a plurality of shareable elements and a plurality of reinforcing expandable elements (figs. 3B-C). The phrase “a flexible carrying element (102, cuff, fig. 3B) . . . being capable of accommodating a plurality of shareable elements and a plurality of reinforcing expandable elements ” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the cuff is considered to be capable of accommodating a plurality of shareable elements and a plurality of reinforcing expandable elements.
The first embodiment of Bishop fails to teach a plurality of shapeable elements and a plurality of reinforcing expandable elements. However, a second embodiment of Bishop teaches
a plurality of shapeable elements (176. Inflatable cuff, fig. 16B) being configured for being adjustable in-situ in size and in shape for self-anchoring and sealing the supporting structure to a native tissue (¶ [0177]) and
a plurality of reinforcing expandable elements (172, stent-like structure, fig. 16B, each ring of struts is an element) being configured and operable to self-anchor and stabilize the supporting structure (¶ [0177]),
wherein the plurality of shapeable elements and the plurality of reinforcing expandable elements are arranged in substantially parallel planes one with respect to the other (fig. 16B) ,
wherein at least one of the plurality of reinforcing expandable elements is positioned above or below a shapeable element of the plurality of shapeable elements (fig. 16B) forcing the shapeable element to expand radially (¶ [0177]),
wherein the plurality of shapeable elements and the plurality of reinforcing expandable elements are completely enclosed within the flexible carrying element (fig. 3B) to thereby create a highly compressible, flexible dynamic supporting structure being capable of accommodating a prosthetic valve (104, valve, fig. 2A),
wherein said flexible carrying element is capable of being shaped in-situ forming a final outer shape according to a patient's anatomy (¶ [0132]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the supporting structure of the first embodiment of Bishop to include a plurality of shapeable elements and a plurality of reinforcing expandable elements as taught by a second embodiment of Bishop in order to minimize or eliminate peri-valvular leaks (Bishop, ¶ [0177]). Bishop indicates the embodiments are combinable in paragraph [0454].
The examiner notes a plurality of shapeable elements and a plurality of reinforcing expandable elements has not been positively recited. The current claim language requires only a flexible carrying element that can accommodate other elements. The plurality of shapeable elements and the plurality of reinforcing expandable elements are only claimed as functional language. The prior art is not required to explicitly disclose the recited function but merely have the capability of performing the recited function in order to meet the claim requirements.
Regarding claim 10, the second embodiment of Bishop teaches each of the plurality of shapeable elements is capable of being filled in-situ separately or simultaneously using at least one filling material (¶ [0177]) enabling sealing and tissue anchoring to a mitral and/or tricuspid and/or semilunar valves while maintaining flexibility and allowing movement with a cardiac cycle (¶ [0177]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the supporting structure of the first embodiment of Bishop to include separate or simultaneous in-situ filling of the shapable elements as taught by a second embodiment of Bishop in order to minimize or eliminate peri-valvular leaks (Bishop, ¶ [0177]).
The examiner notes a plurality of shapeable elements has not been positively recited. The current claim language requires only a flexible carrying element that can accommodate a plurality of shapable elements. The plurality of shapeable elements is only claimed as functional language. The prior art is not required to explicitly disclose the recited function but merely have the capability of performing the recited function in order to meet the claim requirements.
Regarding claim 15, the second embodiment of Bishop further teaches one of the reinforcing expandable elements defines a fixed inner dimension of the open cavity (fig. 16B, the inner dimension is fixed when the stent-like structure reaches it terminal diameter) and is configured and operable to maintain stability at an annular level (fig. 2A). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the supporting structure of the first embodiment of Bishop to include a fixed inner dimension of the open cavity as taught by a second embodiment of Bishop in order to minimize or eliminate peri-valvular leaks (Bishop, ¶ [0177]).
The examiner notes a plurality of reinforcing expandable elements has not been positively recited. The current claim language requires only a flexible carrying element that can accommodate a plurality of reinforcing expandable elements. The plurality of reinforcing expandable elements is only claimed as functional language. The prior art is not required to explicitly disclose the recited function but merely have the capability of performing the recited function in order to meet the claim requirements.
Regarding claim 16, the second embodiment of Bishop further teaches at least some of the plurality of reinforcing expandable elements have the same or different physical properties including at least one of shape or diameter (fig. 16B, same shape). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the supporting structure of the first embodiment of Bishop to include the plurality of reinforcing expandable elements have the same or different physical properties as taught by a second embodiment of Bishop in order to minimize or eliminate peri-valvular leaks (Bishop, ¶ [0177]).
The examiner notes a plurality of reinforcing expandable elements has not been positively recited. The current claim language requires only a flexible carrying element that can accommodate a plurality of reinforcing expandable elements. The plurality of reinforcing expandable elements is only claimed as functional language. The prior art is not required to explicitly disclose the recited function but merely have the capability of performing the recited function in order to meet the claim requirements.
Regarding claim 19, the second embodiment of Bishop teaches each of the at least shapeable elements and of the plurality of reinforcing elements has a closed-loop configuration providing substantially 360 degrees sealing between the supporting structure and a native tissue according to a patient's anatomy (fig. 2A). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the supporting structure of the first embodiment of Bishop to include a closed-loop configuration as taught by a second embodiment of Bishop in order to minimize or eliminate peri-valvular leaks (Bishop, ¶ [0177]).
The examiner notes a plurality of shapeable elements and a plurality of reinforcing expandable elements has not been positively recited. The current claim language requires only a flexible carrying element that can accommodate other elements. The plurality of shapeable elements and the plurality of reinforcing expandable elements are only claimed as functional language. The prior art is not required to explicitly disclose the recited function but merely have the capability of performing the recited function in order to meet the claim requirements.
Regarding claim 20, a first embodiment of Bishop teaches a plurality of prosthetic valves leaflets being coupled with the supporting structure (104, valve, fig. 5B), wherein the plurality of prosthetic valve leaflets is configured and operable as a one-way valve (¶ [0131]).
Claim(s) 3-5, 7-8 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bishop in view of Piccagli.
Regarding claim 3, Bishop fails to teach the flexible carrying element is made of an elastic material or a material promoting rapid endothelial growth. However, Piccagli teaches an endoluminal prosthetic that includes a sealing material made of an elastic material (¶ [0053]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the material of Bishop to include an elastic material as taught by Piccagli since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 4, Bishop fails to teach a rough textured external surface. However, Piccagli further teaches an external surface having a rough texture enabling to self-anchor the supporting structure to a native tissue (¶ [0053]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the material of Bishop to include a rough textured external surface as taught by Piccagli since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 5, Bishop fails to teach a mesh-like pattern or a dot-like pattern, or a grid-like pattern. However, Piccagli further teaches a mesh-like pattern or a dot-like pattern, or a grid-like pattern (¶ [0053]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the material of Bishop to include a mesh-like pattern or a dot-like pattern, or a grid-like pattern as taught by Piccagli since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 7, Bishop fails to teach an internal surface made of a material allowing smooth and liner blood flow. However, Piccagli further teaches an internal surface interfacing the open cavity being made of a material allowing smooth and linear blood flow and preventing thrombogenicity and turbulent flow (¶ [0053]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the material of Bishop to include an internal surface made of a material allowing smooth and liner blood flow as taught by Piccagli since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 8, Bishop fails to teach a non-thrombogenic fabric mesh portion. However, Piccagli further teaches at least one non-thrombogenic fabric mesh portion (¶ [0053]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the material of Bishop to include a non-thrombogenic fabric mesh portion as taught by Piccagli since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 12, a first embodiment of Bishop teaches at least one filling material comprises at least one fluid being in the form of at least one of gas, liquid, gel, powder, or granules or any combination thereof (¶ [0208]).
Claim(s) 26-27 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bishop in view of Lenker (US 5,824,041 A).
Regarding claim 26, Bishop further teaches
a sterile catheter (300, delivery catheter, fig. 34) being accommodated within said container, the sterile catheter having a distal end (307, distal end, fig. 34) and a proximal end (303, proximal end, fig. 34);
a sterile prosthetic valve being accommodated within the container (100, implant, fig. 34, the valve is housed within the catheter which is within the container); wherein -said sterile prosthetic valve is removably coupled to the distal end of the sterile catheter (¶ [0262-0263]), wherein the sterile prosthetic valve includes a plurality of prosthetic valve leaflets (104, valve, fig. 5B) being coupled to a flexible collapsed supporting structure as defined in claim 1; and
a filling material (¶ [0177] and ¶ [0208]) being accommodated within said container and being capable of filling the flexible collapsed supporting structure (¶ [0260]) and deploying the sterile prosthetic valve onto a native mitral valve and/or tricuspid valve and/or semilunar valves (¶ [0262] and ¶ [0355]).
Bishop fails to teach a container capable of providing a sterile barrier. However, Lender teaches an apparatus for placement of intraluminal prostheses that includes a container capable of providing a sterile barrier (sterile pouch, col 1 lines 32-59). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the kit of Bishop to include a container providing a sterile barrier as taught by Lenker since it is combining prior art element according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143) in order to prevent contamination of the catheter prior to implantation.
Regarding claim 27, Bishop further teaches an injection device (320, inflation tubes, fig. 36A) being removably coupled to said container (the container holds the injection device until implantation); said injection device being capable of filling and shaping the flexible supporting structure according to a patient's anatomy (¶ [0260]). The phrase “injection device being capable of filling and shaping the flexible supporting structure according to a patient's anatomy” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the inflation tubes is considered to be capable of filling and shaping the flexible supporting structure according to a patient's anatomy.
Regarding claim 30, Bishop further teaches the flexible collapsed supporting structure is capable of being prefilled with at least a part of the filling material. The phrase “the flexible collapsed supporting structure is capable of being prefilled with at least a part of the filling material ” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the cuff is considered to be capable of being prefilled with at least a part of the filling material.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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