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 .
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.
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) 1-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuseth et al. (US 2017/0197019) in view of one of ordinary skill in the art.
Tuseth et al. discloses:
A cannula comprising:
A conduit having an exterior surface and an interior surface that includes a single piece of a first graft component arranged along the interior surface and being everted over a first end a second end of the conduit to reduce disruption of fluid flow along the interior surface of the conduit;
E.G. via the disclosed P pump which is configured to anchor a fluid regulation device used in order to improve flow pattern of the blood released into a receiving compartment ([0029], [0034], [0122] & (Fig 2)}, wherein the neck 2 is directly associated with the introduction of the pump P in order to prevent fluid passage [0134].
*Note that the examiner is interpreting the disclosed pump as being the claimed conduit and the neck as being the graft component.
and a support structure including an elongate element, the elongate element being coupled to the exterior surface of the conduit by a second graft component and extending along a length thereof.
E.G. via the disclosed delivery catheter 7 that is allows the connector 1 to be inserted within {[0129] & (Fig 1)}, wherein the neck 2 is directly associated with said catheter, i.e. the arms 3A-3B and 4A-4B extend parallel to the neck so that they can fit is said catheter {[0129]-[0130] & (Figs 13 & 14A)}.
Note: The examiner is interpreting the disclosed neck, which is integrally formed with the each arm 3A-4B serves, as the first and second graft components, which provides movement for the disclosed primary and second securing means, i.e. the arms 3A-4B {[0116]-[0118], [0123] & (Figs. 5 & 8)}.
Tuseth et al. discloses that the arms 3A-4B are positioned parallel to the neck so that they fit within the delivery catheter 7 which is further used a delivery configuration for the insertion of the medical device ([0129]-[0132]) except wherein aid catheter has a rectangular cross-section. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the catheter with having a rectangular cross-sectional since it has been held that discovering an optimum shape of a result effective variable only involves routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
2.
The cannula of claim 1, further including an anchoring structure arranged adjacent an end of the conduit configured to engage with tissue and anchor the conduit.
E.G. via the disclosed primary and secondary securing means as referred to the arms 3A-4B {[0116]-[0117] & (Fig. 2)}.
3.
The cannula of claim 2, wherein the anchoring structure includes a first anchor portion having a stent portion extending along the exterior surface of the conduit to facilitate folding of the first anchor portion toward the exterior surface of the conduit in a delivery configuration,
and a second anchor portion having a stent portion extending along the exterior surface of the conduit to facilitate folding of the second anchor portion toward the exterior surface of the conduit in a delivery configuration.
E.G. via the disclosed arms 3A-4B extending parallel from the neck so that the can fit within the delivery catheter 7 and be part of the delivery configuration {[0129]-[0132] & (Figs 14A)}.
4.
The cannula of claim 1, further comprising an integrated collar arranged at one of the first end or the second end of the conduit configured to interface with a pump device and lessen an opportunity for collapse of the conduit during operation of the pump device.
E.G. via the disclosed neck comprising a means for retaining the pump P such as a twist and lock or screw mean on its inner surface ([0125]-[0126]).
5.
The cannula of claim 4, wherein the integrated collar includes a plurality of windows and a third graft component is arranged about the integrated collar at the plurality of windows to secure the integrated collar to the conduit.
E.G. (Fig. 5 & 8).
6.
The cannula of claim 1, wherein the conduit is configured to interface with a pump device, and the support structure is configured to resist collapse of the conduit during operation of the pump device.
E.G. ([0125]-[0126]).
7.
The cannula of claim 1, wherein the interior surface of the conduit is configured to reduce thrombus formation, the interior surface of the conduit having a substantially uninterrupted surface.
E.G. ([0125]-[0126]).
8.
A cannula comprising: a conduit having an exterior surface and an interior surface, a proximal end and a distal end;
E.G. via the disclosed P pump which is configured to anchor a fluid regulation device used in order to improve flow pattern of the blood released into a receiving compartment ([0029], [0034], [0122] & (Fig 2)},
*Note that the examiner is interpreting the disclosed pump as being the claimed conduit
an anchoring structure attached to the conduit adjacent an end of the conduit, the anchoring structure including: a first anchor portion having a plurality of first contact features and a first stent element extending along the exterior surface of the conduit toward the distal end of the conduit,
and a second anchor portion having a plurality of second contact features and a second stent element extending along the exterior surface of the conduit toward the proximal end of the conduit, the first stent element being configured to facilitate folding of the first anchor portion toward the exterior surface of the conduit and adjacent the second stent element and the second stent element is configured to facilitate folding of the second anchor portion toward the exterior surface of the conduit and adjacent the first stent element in a delivery configuration.
E.G. via the disclosed primary and secondary securing means referred to as the arms 3A-4B {[0116]-[0117] & (Fig. 2)} wherein the arms 3A-4B extend parallel from a neck 2 so that the arms can fit within a delivery catheter 7 and be part of the delivery configuration {[0129]-[0132] & (Figs 14A)}.
*Note: The examiner is interpreting the arms 3A-4B of the primary and secondary securing means as being the anchoring structure including a plurality of contact features and the neck 2, which is integrally formed with the each arm 3A-4B serves, as being the first and second stent elements configured to facilitate folding, which provides movement for the disclosed primary and second securing means, i.e. the arms 3A-4B {[0116]-[0118], [0123] & (Figs. 5 & 8)}.
9.
The cannula of claim 8, wherein the plurality of first of the first contact features and the secondary plurality of contact features each include a first substantially linear section extending from the exterior surface of the conduit in a first direction, a second substantially linear section extending in a second direction, different for the first direction, to an apex, a third substantially linear section extending in a third direction opposite the second direction, and a fourth substantially linear section extending toward the conduit in a fourth direction opposite the first direction.
E.G. via the disclosed primary and secondary securing means, i.e. arms 3A-4B, for securing the neck 2 across the anatomical walls {[0115]-[0116] & (Fig 10)}.
10.
The cannula of claim 9, wherein the first substantially linear section and the fourth substantially linear section are of approximately a common length.
E.G. {[0115]-[0116] & (Fig 10)}.
11.
The cannula of claim 9, wherein the second substantially linear section and the third substantially linear section are of approximately a common length.
E.G. {[0115]-[0116] & (Fig 10)}.
12.
The cannula of claim 11, wherein the length of the first substantially linear section and the fourth substantially linear section is less than the length of the second substantially linear section and the third substantially linear section.
E.G. {[0115]-[0116] & (Fig 10)}.
13.
The cannula of claim 8, wherein a space between the first anchor portion and the second anchor portion is between about 0 mm to about 2 mm.
Tuseth et al. discloses the claimed invention has a spaced-apart, primary and a secondary securing means, i.e. the arms 3A-4B, associated with the neck 2 of the device except for said space between the primary and secondary securing means is between about 0 mm to about 2 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a spacing between the primary and secondary securing means between about 0 mm to about 2 mm since it has been held that where general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
14.
The cannula of claim 8, wherein the first anchor portion and the second anchor portion are configured to collapse toward the exterior surface of the conduit in the delivery configuration.
E.G. via the disclosed arms 3A-4B extending parallel from the neck so that the can fit within the delivery catheter 7 and be part of the delivery configuration {[0129]-[0132] & (Figs 14A)}.
15.
The cannula of claim 8, wherein the first anchor includes a first stent element arranged along the exterior surface of the conduit, and the second first anchor portion includes a second stent element arranged along the exterior surface of the conduit.
E.G. via the disclosed wherein the arms 3A-4B extend parallel from a neck 2 so that the arms can fit within a delivery catheter 7 and be part of the delivery configuration {[0116]-[0118], [0129]-[0132] & (Figs 14A)}.
*Note: the neck 2, which is integrally formed with the each arm 3A-4B serves, as being the first and second stent elements configured to facilitate folding, which provides movement for the disclosed primary and second securing means, i.e. the arms 3A-4B {[0116]-[0118], [0123] & (Figs. 5 & 8)}.
16.
The cannula of claim 15, wherein the first stent element extends along the exterior surface of the conduit toward and past the second anchor portion and the second stent element extends along the exterior surface of the conduit toward and past the first anchor portion.
E.G. {[0116]-[0118], [0123] & (Figs. 5 & 8)}.
17.
The cannula of claim 15, wherein the first stent element is looped back toward the first anchor portion and the second stent element is looped back toward the second anchor portion.
E.G. {[0116]-[0118], [0123] & (Figs. 5 & 8)}.
18.
The cannula of claim 8, wherein each of the plurality of first contact features have a diamond shape and each of the plurality of second contact features have a diamond shape.
E.G. {[0116]-[0118], [0123] & (Figs. 5 & 8)}.
19.
A cannula comprising: a conduit having an exterior surface and an interior surface;
E.G. via the disclosed P pump which is configured to anchor a fluid regulation device used in order to improve flow pattern of the blood released into a receiving compartment ([0029], [0034], [0122] & (Fig 2)}.
an anchoring structure arranged adjacent an end of the conduit configured to engage with tissue and anchor the conduit, the anchoring structure including: a first anchor portion having a plurality of first contact features extending longitudinally outward relative to the exterior surface of the conduit and a stent portion extending along the exterior surface of the conduit to facilitate folding of the first anchor portion toward the exterior surface of the conduit and in a first direction in a delivery configuration, and
a second anchor portion having a plurality of second contact features extending longitudinally outward relative to the exterior surface of the conduit and a stent portion extending along the exterior surface of the conduit to facilitate folding of the second anchor portion toward the exterior surface of the conduit and in a second direction opposite the first direction in the delivery configuration.
E.G. via the disclosed primary and secondary securing means referred to as the arms 3A-4B {[0116]-[0117] & (Fig. 2)} wherein the arms 3A-4B extend parallel from a neck 2 so that the arms can fit within a delivery catheter 7 and be part of the delivery configuration {[0129]-[0132] & (Figs 14A)}.
*Note: The examiner is interpreting the arms 3A-4B of the primary and secondary securing means as being the anchoring structure including a plurality of contact features and the neck 2, which is integrally formed with the each arm 3A-4B serves, as being the first and second stent elements configured to facilitate folding, which provides movement for the disclosed primary and second securing means, i.e. the arms 3A-4B {[0116]-[0118], [0123] & (Figs. 5 & 8)}.
20.
The cannula of claim 19, wherein the first stent element extends along the exterior surface of the conduit toward and past the second anchor portion and the second stent element extends along the exterior surface of the conduit toward and past the first anchor portion.
E.G. [0128].
21.
The cannula of claim 19, wherein the first stent element is looped back toward the first anchor portion and the second stent element is looped back toward the second anchor portion.
E.G. [0128].
22.
The cannula of claim 19, wherein the first stent element is configured to facilitate folding of the first anchor portion toward the exterior surface of the conduit and adjacent the second stent element and the second stent element is configured to facilitate folding of the second anchor portion toward the exterior surface of the conduit and adjacent the first stent element in the delivery configuration
E.G. {[0128]-[0132] & (Figs 14A)}.
23.
The cannula of claim 19, wherein the plurality of first contact features and the second plurality of contact features each include a first substantially linear section extending from the exterior surface of the conduit in a first direction, a second substantially linear section extending in a second direction, different than the first direction, to an apex, a third substantially linear section extending in a third direction opposite the second direction, and a fourth substantially linear section extending toward the conduit in a fourth direction opposite the first direction.
E.G. via the disclosed primary and secondary securing means, i.e. arms 3A-4B, for securing the neck 2 across the anatomical walls {[0115]-[0116] & (Fig 10)}.
24.
The cannula of claim 19, further including a connector that is integrated to the conduit configured to facilitate attachment to a pump and reduction of thrombus formation.
E.G. via the disclosed P pump which is configured to anchor a fluid regulation device used in order to improve flow pattern of the blood released into a receiving compartment ([0029], [0034], [0122] & (Fig 2)},
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/ Primary Examiner, Art Unit 3796