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.
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: “coupling mechanism” in claims 1, 3-5, 10.
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, 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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Righini (20160346080) in view of Hariton (11793633) and Karapetian (20170209265)
With regards to claim 1, Righini discloses a prosthesis for a heart valve for implantation with a transcatheter procedure (FIG 14E), the prosthesis comprising an expansible central body (63, [0117]) and a containment portion (60) having at least one sub- component (FIG 14B), the central body (63) being provided with at least one elastically flexible arm (64) ending in a connecting block (64a, 64b) for connecting the at least one sub-component of the containment portion to the central body ([0113], FIG 14C), but fails to disclose the at least one arms being formed so as to be able to take up an expanded configuration, into which expanded configuration the at least one arm returns without any constraints, and a compact configuration suitable for allowing the positioning of the prosthesis with a transcatheter procedure, the connecting block being provided with a coupling mechanism configured for selectively maintaining the at least one arm in the compact configuration.
Hariton also discloses a prosthesis for a heart valve for implantation with a transcatheter procedure (FIG 5A), the prosthesis comprising an expansible central body (32), a containment portion (25), and flexible arms (46). Hariton teaches at least one arms (46) being formed so as to be able to take up an expanded configuration (FIG 5A), into which expanded configuration the at least one each arm returns without any constraints (FIG 5A), and a compact configuration suitable for allowing the positioning of the prosthesis with a transcatheter procedure (FIG 2). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Righini’s prosthesis for a heart valve to include that the at least one arms being formed so as to be able to take up an expanded configuration, into which expanded configuration the at least one each arm returns without any constraints, and a compact configuration suitable for allowing the positioning of the prosthesis with a transcatheter procedure, , as taught by Hariton, in order to allow the implant to be delivered in a compressed state (col 1, line 57).
Righini as modified by Hariton fails to disclose the connecting block being provided with a coupling mechanism configured for selectively maintaining the at least one arm in the compact configuration. Karapetian also discloses an apparatus for replacing native heart valves with arms (1606) that are biased towards one configuration (FIG 66B, [0290]) and a connecting block (1614). Karapetian teaches the connecting block (1614) being provided with a coupling mechanism configured for selectively maintaining the at least one arm in the compact configuration (141, 1614, [0290]; This element is interpreted under 112(f) as a set of block with coaxial through-holes that can receive a connecting element, see page 14 of the instant application, and equivalents thereof)). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Righini’s prosthesis for a heart valve to include that the connecting block being provided with a coupling mechanism configured for selectively maintaining the at least one arm in the compact configuration, as taught by Karapetian, in order to restrain the arms while in the catheter and selectively release them to be in the appropriate position to engage ([0290], [0294]).
With regards to claim 2, Righini as modified by Hariton and Karapetian discloses the prosthesis for a heart valve according to claim 1, wherein the at least one arm is curved in the expanded configuration (Hariton FIG 5A) and is aligned approximately along an axis (A) of the prosthesis in the compact configuration (Hariton FIG 2).
With regards to claim 3, Righini as modified by Hariton and Karapetian discloses the prosthesis for a heart valve according to claim 1, further comprising an elongate element (Karapetian 141), the coupling mechanism (Karapetian 141, 1614, [0290]; This element is interpreted under 112(f) as a set of block with coaxial through-holes that can receive a connecting element, see page 14 of the instant application, and equivalents thereof) being configured for coupling the connecting block (Karapetian 1614) with the elongate element (Karapetian 141) (Karapetian FIG 66C), the elongate element being selectively slidable coaxially relative to the prosthesis (Karapetian [0294]). Note that the prior art does not need to disclose the limitation “the elongate element being selectively rotatable angularly” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “or”.
With regards to claim 4, Righini as modified by Hariton and Karapetian discloses the prosthesis for a heart valve according to claim 1, wherein the at least one sub-component of the containment portion comprises at least two sub-components (Rignihi FIG 9A) and the at least one arm comprises at least two arms each ending in a connecting block (Rignihi FIG 9B), the coupling mechanisms of the connecting blocks (Karapetian 141, 1614, [0290]; This element is interpreted under 112(f) as a set of block with coaxial through-holes that can receive a connecting element, see page 14 of the instant application, and equivalents thereof) together forming a mutual coupling mechanism (Karapetian FIG 66C), configured for maintaining the connecting blocks coupled to one another (Karapetian FIG 66C).
With regards to claim 5, Righini as modified by Hariton and Karapetian discloses the prosthesis for a heart valve according to claim 4, wherein the mutual coupling mechanism (Karapetian 141, 1614, [0290]; This element is interpreted under 112(f) as a set of block with coaxial through-holes that can receive a connecting element, see page 14 of the instant application, and equivalents thereof) comprises a housing seat for a slidable elongate element (Karapetian 1608), the housing seat being formed on each of the connecting blocks such that a presence of the slidable elongate element in the housing seat in each of the connecting blocks couples the connecting blocks to one another and arranges the at least two arms in the compact configuration (Karapetian FIG 66C).
With regards to claim 6, Righini as modified by Hariton and Karapetian discloses the prosthesis for a heart valve according to claim 4, wherein the connecting blocks are mutually identical (Karapetian FIG 66D).
With regards to claim 7, Righini as modified by Hariton and Karapetian discloses the prosthesis for a heart valve according to claim 5, wherein the housing seat for the slidable elongate element of each connecting block comprises a through-hole (Karapetian 1614).
With regards to claim 8, Righini as modified by Hariton and Karapetian discloses the prosthesis for a heart valve according to claim 5, wherein the housing seat for the slidable elongate element of each connecting block (Karapetian 1608) comprises a channel defining a longitudinal direction, the channel being formed such that the slidable elongate element is insertable in the channel of each connecting block only by sliding in the longitudinal direction (Karapetian FIG 66C, the channel defines the direction that the elongate element must be inserted in).
With regards to claim 9, Righini as modified by Hariton and Karapetian discloses wherein the respective housing seats of each connecting block each comprise a groove (Karapetian 1614), the grooves of the respective connecting blocks being formed such that, when the connecting blocks are mutually adjacent, the connecting blocks form a channel for the slidable elongate element (Karapetian FIG 66C), the slidable elongate element being insertable in the channel by sliding in a longitudinal direction of the channel (Karapetian FIG 66C).
With regards to claim 10, Righini discloses a method for arranging a prosthesis in an implantation device for a transcatheter procedure comprising the steps of: providing a containment portion (60) having at least one sub-component (FIG 14B), providing an expansible central body (63) having at least one elastically flexible arm (64) ending in a connecting block (64a, 64b) for connecting the at least one sub-component of the containment portion to the central body ([0113], FIG 14C), and crimping the expansible central body (FIG 4, [0069], but fails to disclose the at least one arm being formed so as to be able to take up an expanded configuration into which expanded configuration the at least one each arm returns without any constraints, and a compact configuration suitable for allowing the positioning of the prosthesis with a transcatheter procedure, providing the connecting block with a coupling mechanism configured for selectively maintaining the at least one arm in the compact configuration; arranging the at least two arms in the compact configuration; coupling the connecting block with the coupling mechanism to maintain the at least one arm in the compact configuration.
Hariton also discloses a prosthesis for a heart valve for implantation with a transcatheter procedure (FIG 5A), the prosthesis comprising an expansible central body (32), a containment portion (25), and flexible arms (46). Hariton teaches the at least one arm (46) being formed so as to be able to take up an expanded configuration into which expanded configuration (FIG 5A) the at least one each arm returns without any constraints (FIG 5A), and a compact configuration suitable for allowing the positioning of the prosthesis with a transcatheter procedure (FIG 2). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Righini’s prosthesis for a heart valve to include that the at least one arms being formed so as to be able to take up an expanded configuration, into which expanded configuration the at least one each arm returns without any constraints, and a compact configuration suitable for allowing the positioning of the prosthesis with a transcatheter procedure, as taught by Hariton, in order to allow the implant to be delivered in a compressed state (col 1, line 57).
Righini as modified by Hariton fails to disclose providing the connecting block with a coupling mechanism configured for selectively maintaining the at least one arm in the compact configuration. Karapetian also discloses an apparatus for replacing native heart valves with arms (1606) that are biased towards one configuration (FIG 66B, [0290]) and a connecting block (1614). Karapetian teaches the connecting block (1614) being provided with a coupling mechanism configured for selectively maintaining the at least one arm in the compact configuration (141, 1614, [0290]; This element is interpreted under 112(f) as a set of block with coaxial through-holes that can receive a connecting element, see page 14 of the instant application, and equivalents thereof). Karapetian also teaches arranging the at least two arms (16060) in the compact configuration (FIG 66C); coupling the connecting block (1604) with the coupling mechanism to maintain the at least one arm in the compact configuration (FIG 66C). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Righini’s prosthesis for a heart valve to include that the connecting block being provided with a coupling mechanism configured for selectively maintaining the at least one arm in the compact configuration; arranging the at least two arms in the compact configuration; and coupling the connecting block with the coupling mechanism to maintain the at least one arm in the compact configuration, as taught by Karapetian, in order to restrain the arms while in the catheter and selectively release them to be in the appropriate position to engage ([0290], [0294]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (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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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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