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.
Specification
The disclosure is objected to because of the following informalities: applicant refers to the central cavity as 143 in [0079], then in [0082] when describing the lower flange as 134, applicant inverts two digits such that the reference character 143 is now used for the lower flange. The typos should be fixed for clarity.
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.
5. 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:
a crimping mechanism incorporated into the storage container and operable to engage a heart valve and convert a heart valve from its expanded configuration to its crimped configuration in claim 1.
For the purposes of examination, the crimping mechanism of claims 1 is understood to be at least a tapered opening.
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.
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.
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) 1-8 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Que et al. (US 2008/0221703).
Regarding claim 1-4, Que discloses a storage container for a prosthetic heart valve ([0025] end of first column to end of paragraph in second column) and fully capable of housing a heart valve comprising:
a container housing 101 sized to receive a valve (implant) 103, [0025], last sentence, in an expanded configuration, fig. 1d; and
a crimping mechanism having a valve cover (narrowing passage) 106 incorporated into the storage container and operable to engaging an implant a heart valve and convert a heart valve from its expanded configuration to its crimped configuration as it passes through a cone-shaped tapered channel extending from a bottom surface of the valve cover toward a central opening (not numbered) in the container [0028]. The central opening (not numbered) is in communication with an interior of the container housing,
Regarding claim 5, Que discloses, fig 1d, a size of an opening to the tapered channel at the bottom surface of the valve cover corresponds to the size of a valve implant in its expanded configuration. The size of the channel opening and implant of Que is not disclosed however the figures show that the sizes correspond to one another.
Regarding claim 6, Que discloses the crimping mechanism includes, fig. 1b:
a top cover 108 coupled to the container housing and having an opening axially aligned with a central opening of the valve cover (opening seen in fig. 1d, 105 passes through the opening);
a base 102 having a central cavity sized and configured to receive a heart valve, the base axially movable with respect to the valve cover (as seen in fig. 1d and 1e) for moving a heart valve through the central opening of the valve cover.
Regarding claim 7, Que discloses that the crimping mechanism further includes:
a valve stage 104 located in a central cavity of the base, the valve stage configured to provide axial support for a heart valve; and
a valve support (the narrowed walls of base 102 provide support to the valve as it passes through the narrowed diameter [0033]) configured to extend axially adjacent a heart valve and to provide radial or lateral support for a heart valve. While the valve support of Que does not directly contact the valve implant, as seen in the figures of the instant application, there is no contact between the valve and the “valve support,” fig. 9A.
Regarding claim 8, the connection between the top cover of Que and the container housing can be seen in fig. 1b and 1d. There is nothing that prevents the top cover from rotating with respect to the container or the valve cover.
With this in mind, the top cover of Que is rotatable coupled with the container housing and the valve cover.
Regarding claim 11, Que discloses a crimping mechanism for a valve and fully capable of housing a prosthetic heart valve comprising:
a valve cover including a central opening extending through a top surface of the valve cover, and tapered channel extending from a bottom surface of the valve cover toward the central opening, the central opening and tapered channel for allowing passage of the heart valve therethrough; and
a base having a central cavity sized and configured to receive a heart valve, the base movable axially with respect to the valve cover for moving a heart valve through the tapered channel and central opening of the valve cover,
wherein movement of a heart valve through at least one of the tapered channel or the central opening converts the heart valve from its expanded configuration to its crimped configuration.
Regarding claim 12, Que discloses that the tapered channel defines a cone-shaped portion, fig. 1f at 106.
Regarding claim 13, Que discloses, fig. 1b and 1d, that a first end of the tapered channel includes adjacent the top surface of the valve cover includes a cylindrically-shaped portion extending between the central opening and the cone-shaped portion, where the cylindrically-shaped portion is sized and configured such that it is capable of functioning to help maintain a heart valve in its crimped configuration as seen in fig. 1f.
Regarding claim 14, Que discloses that a size of an opening to the tapered channel at the bottom surface of the valve cover corresponds to the size of a heart valve in its expanded configuration, fig. 1d.
Regarding claim 15, Que discloses that the crimping mechanism comprises a valve stage 104 located in a central cavity of the base, the valve stage configured to provide axial support for a heart valve; and
a valve support (the narrowed walls of base 102 provide support to the valve as it passes through the narrowed diameter [0033]) configured to extend axially adjacent a heart valve and to provide radial or lateral support for a heart valve. While the valve support of Que does not directly contact the valve implant, as seen in the figures of the instant application, there is no contact between the valve and the “valve support,” fig. 9A.
Claim(s) 1-5, 11, 12, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mearns et al. (US 2012/0101569).
Regarding claims 1 and 2, Mearns discloses a storage container 300 for a prosthetic heart valve 200 (the prosthesis is described as a heart valve in [0004]) comprising:
a container housing 302 (cap) sized to receive a heart valve in an expanded configuration; and
a crimping mechanism valve cover 204 (reducing member) with a central opening at 352, fig. 4A, in communication with an interior of the container housing, fig. 11, the crimping mechanism incorporated into the storage container and operable to engage a heart valve and convert a heart valve from its expanded configuration to its crimped configuration as it passes through an opening in the container.
Regarding claim 3, Mearns discloses the valve cover includes a tapered channel extending from a bottom surface of the valve cover toward the central opening, fig. 4A,
wherein movement of a heart valve through the tapered channel converts the heart valve from its expanded configuration to its crimped configuration, [0052].
Regarding claim 4, Mearns discloses the tapered channel defines a cone-shaped passage, [0052]: “conical wall 342.”
Regarding claim 5, Mearns discloses, fig. 11, a size of an opening to the tapered channel at the bottom surface of the valve cover corresponds to the size of a heart valve in its expanded configuration.
Regarding claims 11, 12, Mearns discloses a crimping mechanism for a prosthetic heart valve comprising a valve cover 304 (reducing member) with a central opening at 352, fig. 4A, in communication with an interior of the container housing, fig. 11, the crimping mechanism incorporated into the storage container and operable to engage a heart valve and convert a heart valve from its expanded configuration to its crimped configuration as it passes through an opening in the container. Mearns discloses a tapered channel with a cone-shaped passage, [0052]: “conical wall 342.”
a base 302 having a central cavity sized and configured to receive a heart valve, the base movable axially with respect to the valve cover for moving a heart valve through the tapered channel and central opening of the valve cover,
wherein movement of a heart valve through at least one of the tapered channel or the central opening converts the heart valve from its expanded configuration to its crimped configuration [0052].
Regarding claim 14, Mearns discloses, fig. 11, a size of an opening to the tapered channel at the bottom surface of the valve cover corresponds to the size of a heart valve in its expanded configuration.
Regarding claim 15, Mearns discloses a valve stage 316 located in a central cavity 330 of the base, the valve stage configured to provide axial support for a heart valve; and
a valve support 324 configured to extend axially adjacent a heart valve and to provide radial or lateral support for a heart valve.
Claim(s) 1-4, 11, 12, 15, 19, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abbate et al. (US 8763222).
Regarding claims 1-3, Abbate discloses a storage container capable of housing a prosthetic heart valve comprising:
a container housing 3710 sized to receive a heart valve in an expanded configuration; and
a crimping mechanism with a valve cover 3702 having a tapered central opening 3704, fig. 37C, that extends toward an upper central opening in the top of the valve cover, the valve cover incorporated into the storage container and fully capable of engaging a heart valve in order to convert a heart valve from its expanded configuration to its crimped configuration as it passes through an opening in the container, fig. 37E.
Regarding claim 4, as seen in fig. 37C, the tapered channel 3704 defines a cone-shaped passage.
Regarding claims 11 and 15, Abbate discloses a crimping mechanism fully capable of housing a prosthetic heart valve, fig. 37B, 37C, 37E comprising:
a valve cover 3702 including a central opening extending through a top surface of the valve cover, and tapered channel 3704 extending from a bottom surface of the valve cover toward the central opening, the central opening and tapered channel for allowing passage of the heart valve therethrough; and
a base 3706 having a central cavity sized and configured to receive a heart valve within walls 3710, the base movable axially (via threads at 3712, fig. 37C) with respect to the valve cover and the axial movement is capable of moving a heart valve through the tapered channel and central opening of the valve cover,
a valve stage 3718 capable of providing axial support to a heart valve, and
a valve support 3716 capable of providing radial or lateral support for a heart valve, as seen in fig. 37E in the situation where the valve support is inserted all the way into the base, as the base moves axially with respect to the valve cover, a heart valve can be pushed through at least one of the tapered channel or the central opening converts the heart valve from its expanded configuration to its crimped configuration.
Regarding claim 12, as seen in fig. 37C, the tapered channel is cone-shaped.
Regarding claim 19, Abbate further discloses the valve support includes axially extending arms at 3716, reference fig. 37A and 38A, that extend from a base structure, the arms extending through openings at 3804 provided in an end surface of the base, col. 22: 5-20.
Regarding claim 20, the device of Abbate is capable of operating such that the valve support remains fixed during axial movement of the base (the valve support can be inserted all the way into the base and then the base can move axially via threads 3712 with respect to the cover 3702, fig. 37C and 37E.
Allowable Subject Matter
Claims 9, 10, 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The threaded top in combination with the base thread, in combination with the other claimed structure is not found in the prior art (claim 9) and the valve arms in combination with the other claimed structure is not found in the prior art (claim 16).
The claims not addressed above are allowed since they depend from an allowed claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOLLIE L IMPINK whose telephone number is (571)270-1705. The examiner can normally be reached Monday-Friday (7:30-3:30).
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, Anthony Stashick can be reached at (571) 272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MOLLIE LLEWELLYN IMPINK
Primary Examiner
Art Unit 3799
/MOLLIE IMPINK/Primary Examiner, Art Unit 3799
Prosecution Insights