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 .
Double Patenting
Claims 1-3, 5-10, 13, 14, 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-6, 9-14 of U.S. Patent No. 11,992,198. Although the claims at issue are not identical, they are not patentably distinct from each other because they have overlapping subject matter has discussed below.
Application 12/241,791
Rejected over US Patent No. 11,992198
Overlapping subject matter
1
1
A device for sealing an aperture in a tissue of a body lumen comprising: a closure device comprising: a flexible support member comprising a base and a sealable member a column comprising a centering tab and/or one or more locking tabs; and an extra-arterial shoe comprising one or more engagement elements for engagement with the flexible support member to secure the closure device; and a delivery system comprising a delivery shaft, wherein the extra-arterial shoe comprises a cylindrical shape and a centerline configured to be collinear with a centerline of the delivery shaft when the extra-arterial shoe is engaged on the delivery shaft.
2, 3
2
wherein the entirety of the extra-arterial shoe is disposed between a first radius around the centerline of the extra-arterial shoe and a second radius around the centerline of the extra-arterial shoe, wherein the second radius is larger than the first radius.
5
4
wherein a body of the extra-arterial shoe is disposed between a first radius around the centerline of the extra-arterial shoe and a second radius around the centerline of the extra-arterial shoe, wherein the second radius is larger than the first radius.
6
5
the extra-arterial shoe further comprising at least one angled prong extending externally away at an angle from the body of the extra-arterial shoe beyond the second radius.
7-10
6
2, 3, 4, 5, or 6 angled prongs spaced around the centerline of the extra-arterial shoe at about 180, 120, 90, 72, or 60 degrees apart
13
9
wherein the base comprises a generally circular planar shape and one or more lateral support portions
14
10
wherein the base comprises at least one space between the one or more lateral support portions and the center of the base.
16
11
wherein the one or more lateral support portions comprise at least one gap
17
12
wherein the one or more lateral support portions comprise two gaps spaced about 180 degrees apart on lateral sides of the base
18
13
wherein the one or more lateral support portions comprise two pairs of gaps comprising a first pair of gaps disposed at a distal end of the base and a second pair of gaps disposed at a proximal end of the base, the first pair and the second pair spaced about 180 degrees apart
19
14
wherein the base comprises: an anterior region extending distally from a distal end of the base, the anterior region disposed between the first pair of gaps
20
14
wherein the base comprises a posterior region extending proximally from a proximal end of the base, the posterior region disposed between the second pair of gaps.
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.
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 sealable member” and “one or more engagement elements” in claim 1.
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 Objections
Claim 11 is objected to because of the following informalities: claim 11 is dependent upon claim11. For purposes of examination and as best understood, claim 11 is being interpreted as being dependent upon claim 1. Appropriate correction is required.
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.
Claim(s) 1-6 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grant et al. US 2013/0274795.
Regarding claim 1, Grant et al. discloses a device for sealing an aperture in a tissue of a body lumen (paragraph 0008) comprising: a closure device (for example, figures 1A, 17A) comprising: (i) a flexible support member comprising a base 20 and a sealable member 60; (ii) a column 20 comprising a centering tab and/or one or more locking tabs (see annotated figure 2A below); and (iii) an extra-arterial shoe 80 comprising one or more engagement elements 80a for engagement with the flexible support member to secure the closure device (pin portion 80a secured with column to hold tissue between base and sealing member, engagement by association when inserted into the device, figures 2A, 2B; Examiner notes the engagement does not require direct contact); and a delivery system comprising a delivery shaft 150 (figure 2C), wherein the extra-arterial shoe comprises a cylindrical exterior shape (see annotated figure 2A below) and a centerline configured to be collinear with a centerline of the delivery shaft when the extra-arterial shoe is engaged on the delivery shaft (see annotated figure 2A below).
PNG
media_image1.png
312
407
media_image1.png
Greyscale
PNG
media_image2.png
288
418
media_image2.png
Greyscale
Regarding claims 2-5, Grant et al. discloses wherein the entirety of the extra-arterial shoe or body is disposed between a first radius around the centerline of the extra-arterial shoe (first radius around shaft 150) and a second radius around the centerline of the extra-arterial shoe (second radius around exterior of cylindrical body portion of column labeled 20 in figure 2A), wherein the second radius is larger than the first radius (shaft radius around shaft 150 is entirely within the body, figure 2A), wherein the first radius is large enough to allow the delivery shaft 150 to be disposed therethrough (figure 2A).
Regarding claim 6, Grant et al. discloses wherein the extra-arterial shoe further comprising at least one angled prong 80 extending externally away at an angle from the body of the extra-arterial shoe beyond the second radius (figure 1A, 2B).
Regarding claim 11, Grant et al. discloses wherein the one or more engagement elements comprise at least one of a notch, a hole, and a groove (may consider notch or hole 83a, 85a, figure 7D), and wherein the extra-arterial shoe comprises at least one material selected from the group consisting of E-caprolactone and Polyethylene glycol (paragraph 0190).
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.
Claim(s) 7-10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grant et al. US 2013/0274795.
Regarding claims 7-10, Grant et al. discloses wherein the extra-arterial shoe comprises 1 prong or a plurality of prongs (prong 80, figure 2B, or 6 prongs 80C, figure 8B), the prongs evenly spaced would result in being spaced about 60 degrees apart (figure 8B), wherein the extra -arterial shoe comprises 2, 3, 4, 5, or 6 angled prongs (figure 8B, alternative embodiments of pin 80 includes a plurality of prongs 80C which may extend radially outward, paragraph 0218, 0219), wherein the extra-arterial shoe comprises 6 angled prongs spaced around the centerline of the extra-arterial shoe about 60 degrees apart (figure 8B, 6 prongs 80C, for example), wherein the extra-arterial shoe comprises 2 angled prongs spaced around the centerline of the extra-arterial shoe (figure 8B, two opposite prongs), but fails to explicitly disclose 2, 3, 4, 5, or 6 angled prongs spaced around the centerline of the extra-arterial shoe about 90 degrees apart, two prongs spaced around the centerline of the extra-arterial shoe about 120 degrees apart (figure 8B, 2 opposite prongs of prongs 80C), Examiner notes the prongs 80C are evenly spaced, the prongs would result in evenly spaced prongs about 60 degrees apart if there were 6 prongs, or two opposite prongs being about 120 degrees apart.
It would have been an obvious matter of design choice to modify Grant et al., to have 1, 2, 3, 4, 5, 6 or other number of angled prongs spaced around the centerline of the extra-arterial shoe and evenly spaced resulting in being about 90 degrees apart or 120 degrees apart, for 4 prongs or 2 prongs respectively, since applicant has not disclosed that having 1, 2, 3, 4, 5, 6 or other number of angled prongs solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to criticality that the extra-arterial shoe has 1, 2, 3, 4, 5, 6 or other number of angled prongs, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Regarding claim 12, Grant et al. further discloses a shoe pusher, wherein the shoe pusher is mounted on the delivery shaft and is slideably moveable along a longitudinal axis of the delivery shaft (paragraph 0255, figure 7A, pusher tube 155 to push shoe 80 and an internal diameter to accept shaft 150).
Claim(s) 1-5 and 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klein et al. US 2014/0200597 in view of Grant et al. US 2013/0274795.
Regarding claim 1, Klein et al. discloses a device for sealing an aperture in a tissue of a body lumen (for example, figure 2) comprising: a closure device comprising: (i) a flexible support member comprising a base 110 (figure 2); (ii) a column 112 comprising a centering tab and/or one or more locking tabs (paragraph 0048, 0049; column 112 comprising a coupling 506 connection surface or centering tabs or snap fit, threads, tines as locking tabs for coupling together); and(iii) an extra-arterial shoe 106 comprising one or more engagement elements for engagement with the flexible support member to secure the closure device (paragraph 0048, 0049, engagement snap fit or teeth to mate together); and a delivery system comprising a delivery shaft 104 or 114 (figure 1), wherein the extra-arterial shoe comprises a centerline configured to be collinear with a centerline of the delivery shaft when the extra-arterial shoe is engaged on the delivery shaft (figure 1, shaft, inner and outer scaffolding or base and shoe are aligned along the longitudinal axis).
Klein et al. fails to disclose wherein the flexible support member comprising a sealable member, or wherein the extra-arterial shoe comprises a cylindrical exterior shape.
However, Klein et al. discloses wherein the base and the extra-arterial shoe may vary in shape (paragraph 0038, may be scalloped circles, elliptical, petal-like or triangular). Although not explicitly disclosed, providing a shape such as a cylindrical shape would have been obvious to one having ordinary skill in the art, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). It would have been an obvious matter of design choice to modify the Klein et al. to have a shoe having a cylindrical exterior shape, since applicant has not disclosed that having this particular shape solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to criticality of a cylindrical exterior shape shoe, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Grant et al. teaches a closure device for use in the tissue of a body lumen, such as the stomach, intestines, colon, or blood vessels (paragraph 0182), and a support member comprising a base (foot 20) and a flexible sealable member 60 which may be made of a flexible material (paragraph 0190) and with pressure against the surface and the flexible wing or sealing member conforming to the luminal topography to help seal the opening (paragraph 0191).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to provide Klein et al. with a flexible sealing member, as taught by Grant et al. to help conform to the tissue topography and help seal the tissue opening.
Regarding claims 2-5, Klein et al. discloses wherein the entirety of the extra-arterial shoe is disposed between a first radius around the centerline of the extra-arterial shoe and a second radius around the centerline of the extra-arterial shoe (first radius around the shaft 114, the second radius surrounding outer perimeter or radius around the body 106), wherein the second radius is larger than the first radius (see annotated figure 1 below), wherein the first radius is large enough to allow the delivery shaft to be disposed therethrough (first radius is surrounding the shaft 114) and wherein a body 106 of the extra-arterial shoe is disposed between a first radius around the centerline of the extra-arterial shoe and a second radius around the centerline of the extra-arterial shoe (figure 1, shoe extends around centerline or shaft 114 and extends outward to the radius of the shoe, or the second radius, therefore within the first and second radius).
PNG
media_image3.png
357
341
media_image3.png
Greyscale
Regarding claim 13-17, Klein et al. discloses wherein the base comprises a generally circular planar shape (figure 3) forming one or more lateral support portions (support portions of frame surrounding perforations 406, figure 3), wherein the base comprises at least one space 406 between the one or more lateral support portions and a center of the base (figure 3), wherein the one or more lateral support portions extend continuously 360 degrees around the center of the base (figure 3), wherein the one or more lateral support portions comprises at least one gap (gap 406 or center opening, figure 3) wherein the one or more lateral support portions comprise two gaps spaced about 180-degrees apart on lateral sides of the base (see annotated figure 3 below).
PNG
media_image4.png
426
637
media_image4.png
Greyscale
Regarding claim 18, Klein et al. discloses wherein the one or more lateral support portions comprise two pairs of gaps comprising a first pair of gaps disposed at a distal end of the base and a second pair of gaps disposed at a proximal end of the base, the first pair and the second pair spaced about 180-degrees apart (for example, see annotated figure 3 below).
PNG
media_image5.png
397
612
media_image5.png
Greyscale
Regarding claims 19 and 20, Klein et al. discloses the shape of the base (inner scaffolding) may vary, including a base which is generally circular (figure 3) and including an embodiment wherein the base may be scalloped circles (paragraph 0038). Examiner notes that a scalloped circle configuration would result in the base comprises an anterior region extending distally from a distal end of the base, the anterior region disposed between the first pair of gaps 406, wherein the base comprises a posterior region extending proximally from a proximal end of the base, the posterior region disposed between the second pair of gaps (scallops drawn partially around the base and extending distally and proximally, as shown in annotated figure 3 below).
PNG
media_image6.png
385
494
media_image6.png
Greyscale
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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, Darwin Erezo can be reached at (571) 272-4695. 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.
/CHRISTINA C LAUER/Examiner, Art Unit 3771
Prosecution Insights