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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-21 is/are pending. Claim(s) 15 is/are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Species 1-1 in the reply filed on 7/17/2026 is acknowledged.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species 1-2, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/17/2026.
Information Disclosure Statement
The information disclosure statements filed 2/12/2025 fail to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites “the first and second”, which should be “the first and the second”.
Appropriate correction is required.
Claim Interpretation - 35 USC § 112, 6th paragraph
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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.
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: see Table I below.
Table I: Language Invoking 112(f)
Claim(s)
Placeholder
Functional Language
Corresponding Structure
(in the Original Specification)
3-5, 10, 12
Mechanisms
Expansion
#404, [0092]
an outer member 432 having an inner cavity or bore (not shown) and an inner member 434 extending at least partially into the bore, [0110]
similar to those disclosed in U.S. Publication No. 2022/0257367, but can exclude the locking means, [0115]
the same as those disclosed in U.S. Publication No. 2022/0257367, [0115] (instant Application)
comprise flexible tension members (as the inner member), [0115]
similar to actuators 200 described above, except that expansion mechanisms 528 need not necessarily include a screw member, [0127]
comprise an inner member 530, a distal nut or sleeve 532 coupled to the sub-frame 504 at a first axial location, and a proximal nut or sleeve 534 coupled to the first sub-frame 504 at a second axial location spaced apart from the first, [0127]
can be expansion and locking mechanisms including a locking member, [0133]
4
Mechanisms
Locking
#200, actuators, [0062], Figure 4
actuator screw #202, [0064], Figures 5A-C
having a sleeve #212, [0066]
found, for example, in U.S. Patent No. 10,603,165, [0081] (instant Application)
found in U.S. Publication No. 2022/0257367, [0115] (instant Application)
6, 21
Member
Flexible tension
wires and/or sutures, [0115], [0120]
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: see Table II below.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Table II: Language Not Invoking 112(f)
Claim(s)
Placeholder
Functional Language
Corresponding Structure
(in the claims)
6, 20
Mechanisms
Expansion
An inner member and an outer member
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 12-21 are 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.
Claim 12 recites “the frame”. It is unclear which of the three frames introduced earlier in the claims is being referred back to. For purposes of examination the Examiner considers this language to be either “the radially compressible and expandable frame” or “the first sub-frame”. The latter is an option because “the expanded configuration” is of “the first sub-frame”.
Claims 18-19 each recites “the frame”. It is unclear which of the three frames introduced earlier in the claims is being referred back to. For purposes of examination the Examiner considers this language to be “the radially compressible and expandable frame”.
Claims 18-19 each recites the limitation "the extending portion of the second sub-frame". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an extending portion of the second sub-frame” in the first instance of this limitation. The Examiner notes on the extending portion of the first sub-frame was previously introduced.
Claim(s) 13-17 and 20-21 are rejected as dependent from a rejected claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-14, 16, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cartledge, et al (Cartledge) (US 2014/0296962 A1).
Regarding Claim 1, Cartledge teaches an implantable prosthetic device (e.g. abstract, Figures 54-63, [0353]), comprising:
a hybrid frame (e.g. Figures 54-63) movable between a radially compressed configuration and a radially expanded configuration (e.g. [0353]),
the hybrid frame comprising:
a mechanically-expandable first sub-frame comprising a plurality of struts pivotably coupled to one another (e.g. Figures 54-57, radially outer frame; [0353], mechanical movement at pivots); and
a plastically-deformable second sub-frame coupled to the first sub-frame (e.g. Figures 54-57, radially inner frame; [0353], the frames of Figures 54-63 are alternate frame shapes for the prior described embodiments; [0333], the frames are made of stainless steel or cobalt chromes which are plastically expandable materials);
wherein, when the hybrid frame is in the radially expanded configuration, the second sub-frame is configured to resist radial compression of the hybrid frame (as the material is a plastic material, the deformation during expansion is permanent and thus the frame resists changes in diameter including that claimed).
Regarding Claim 2, the second sub-frame is disposed radially inwardly of the first sub-frame (e.g. Figures 54-57; discussed supra for claim 1).
Regarding Claim 3, there is one or more expansion mechanisms coupled to the first sub-frame (e.g. [0353], fasteners; [0352], screws, rivet system), the one or more expansion mechanisms configured to move the first sub-frame between the radially compressed configuration and the radially expanded configuration (e.g. [0353]).
Regarding Claim 4, the one or more expansion mechanisms do not comprise locking mechanisms (e.g. [0352], at least the rivet system allows for strut pivoting after placed to hold the two sub-frames together).
Regarding Claim 5, the first and second sub-frames are coupled to one another via the one or more expansion mechanisms (discussed supra for claims 3-4; e.g. [0352]-[0353]).
Regarding Claim 7, the second sub- frame is formed as a unitary piece of material (e.g. Figures 54-55).
Regarding Claim 8, there are a plurality of projections is formed on the second sub-frame and coupling the second sub-frame to the first sub-frame comprises inserting the plurality of projections through corresponding apertures in the first sub-frame (e.g. [0352], where the protrusion extends from the second sub-frame toward the first sub-frame).
Regarding Claim 9, there is a valvular structure including a plurality of leaflets (e.g. [0354]; [0019], valve shown in e.g. Figure 64; [0022]), the valvular structure coupled to the second sub-frame (as the valvular structure is within the frames it is, as broadly claimed, coupled to each).
Regarding Claim 10, there is valvular structure including a plurality of leaflets, the valvular structure coupled to the one or more expansion mechanisms (e.g. [0022], valvular structure as seen in Figure 64 has three leaflets).
Regarding Claim 11, the second sub-frame comprises at least one of cobalt-chrome and stainless steel (e.g. [0333]).
Regarding Claim 12, Cartledge teaches an implantable prosthetic device (discussed supra for claim 1), comprising:
a radially compressible and expandable frame (discussed supra for claim 1),
the frame comprising:
a mechanically expandable first sub-frame (discussed supra for claim 1) comprising one or more expansion mechanisms (discussed supra for claim 3) configured to move the first sub-frame between a radially compressed configuration and a radially expanded configuration (discussed supra for claim 3); and
a plastically-deformable second sub-frame coupled to the first sub-frame (discussed supra for claim 1), the second sub-frame configured to prevent radial compression of the frame from the expanded configuration (discussed supra for claim 1).
Regarding Claim 13, there is a valvular structure including a plurality of leaflets, the valvular structure coupled to the second sub-frame (discussed supra for claim 9). Regarding Claim 14, the second sub-frame is disposed radially inwardly of the first sub-frame (discussed supra for claim 2).
Regarding Claim 16, there is a valvular structure including a plurality of leaflets, the valvular structure being coupled to the first sub-frame (discussed supra for claim 2, which describes how the valvular structure is coupled to both the first and the second sub-frames).
Regarding Claim 20, each expansion mechanism of the one or more expansion mechanisms comprises an outer member coupled to the frame at a first location and an inner member coupled to the frame at a second location spaced apart from the first location (discussed supra for claims 3 and 5; the locations are spaced at least while the two sub-frames are being attached but aren’t contacting each other).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge, et al (Cartledge) (US 2014/0296962 A1) as discussed supra, alone.
Regarding Claims 6 and 21, Cartledge discloses the invention substantially as claimed but fails to teach each expansion mechanism of the one or more expansion mechanisms comprises an inner member and an outer member, and wherein the inner member comprises a flexible tension member.
Cartledge teaches in the embodiment of Figures 7-8 an expansion mechanism (e.g. [0323], assembly #700) comprising an outer member coupled to the frame at a first location (e.g. Figure 7, #s 720/730) and an inner member coupled to the frame at a second location spaced apart from the first location (e.g. Figure 7, #s 710/740; axially spaced apart before connection), the one or more expansion mechanisms coupled to the first sub-frame (e.g. Figures 7-8; coupled to both the first and second sub-frames), and the one or more expansion mechanisms configured to move the first sub-frame between the radially compressed configuration and the radially expanded configuration (e.g. [0323]).
Cartledge teaches the inner member comprises a flexible tension member (e.g. Figures 21-26, [0337]; wire #2182).
Both embodiments of Cartledge are concerned with the same field of endeavor as the claimed invention, namely heart valves with struts connected at pivot points.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cartledge’s Figures 54-63 by incorporating the extension mechanisms of the embodiment of Figures 7-8, 21-26 in order to provide controlled delivery and recapture means (e.g. [0329]-[0330]).
Claims 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge, et al (Cartledge) (US 2014/0296962 A1) as discussed supra and further in view of White (US 2014/0277563 A1).
Regarding Claim 17, Cartledge discloses the invention substantially as claimed but fails to teach the second sub-frame is axially longer than the first sub-frame and comprises an extending portion that extends axially past the first sub-frame.
White teaches a heart valve frame with struts connected at pivot points (e.g. Figures 26-28) having an extending portion (e.g. Figures 26-28, #s 2659).
White and Cartledge are concerned with the same field of endeavor as the claimed invention, namely heart valves with struts connected at pivot points.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cartledge by incorporating the extending portion as taught by White in order to provide artificial leaflet connections that may expand and contract along with the configurational changes to the longitudinal strut members, without generating significantly more resistance or stress in the structure (e.g. White, [0138]).
The combination of Cartlidge and White teaches the second sub-frame is axially longer than the first sub-frame (the extending portion is on the second sub-frame and thus the second sub-frame is axially longer than the first sub-frame).
Regarding Claim 18, the frame is configured to be implanted such that the first sub-frame is positioned within a native aortic annulus and the extending portion of the second sub-frame wedges open one or more native leaflets (e.g. [0010], [0020]; as the extending portion extends axially and there is one for each commissure, they are able to wedge open the leaflets).
Regarding Claim 19, the frame is configured to be implanted such that the extending portion of the second sub-frame is positioned within a native aortic annulus and the first sub-frame wedges open one or more native leaflets (e.g. [0010], [0020]; as both sub-frames expand the annulus open, each is able to wedge open the leaflets).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JERRAH EDWARDS can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 8/6/2026
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