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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the outflow port configured for arrangement after implantation in the right atrium and right ventricle (required by claim 1) which also includes a distal end pointing in a directed toward the base of the heart (claim 3) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: In paragraph 57 of Applicant’s published application, the angle projecting toward the apex of the heart is described as upward projecting and the angle projecting towards the base of the heart is descried as downward projecting. This appears to be the opposite to the locations of the apex and base of the heart (towards the base of the heart should be upward projecting, and towards the apex of the heart should be downward projecting).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification fails to describe an outflow port configured for arrangement after implantation in the right atrium and right ventricle (required by claim 1) which also includes a distal end pointing in a directed toward the base of the heart. In particular, the configuration in which the port is arranged in the right ventricle appears to require a distal end that points towards the apex of the heart.
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 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 “stopper position” and “stopper portion” while appearing to refer to the same claim feature.
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.
Claims 1-7, 10-19, 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Greenberg (Pub. No.: US 2006/0276813).
Greenberg discloses a stent graft device configured for implantation into the inferior vena cava and the superior vena cava of a patient to treat a diseased or otherwise damaged tricuspid valve of the patient (fig. 9), the device comprising:
a tubular body 10a having a longitudinal axis and configured for implantation within the superior vena cava (SVC) and the inferior vena cava (IVC), such that, upon implantation, a first end and associated first end portion of the tubular body is arranged in the IVC, and a second end and associated second end portion of the tubular body is arranged in the SVC (fig. 9);
a first outflow port 82 configured for arrangement after implantation in the right atrium and right ventricle (fig. 9), and configured for the fixation of a surgical or transcatheter valve 20 (fig. 9), wherein the first outflow port:
is arranged laterally to the longitudinal axis (fig. 9); and
optionally, automatically deploys upon exiting a delivery catheter (this is not a required feature of the claims).
For claim 2, Greenberg discloses the device of claim 1, wherein the first outflow port is arranged laterally to the longitudinal axis and at an oblique angle to the longitudinal axis (fig. 9).
For claim 3, Greenberg discloses the device of claim 1, wherein the first outflow port is arranged lateral to the longitudinal axis and at an oblique angle to the longitudinal axis, with a distal end of the first outflow port pointing in a direction toward the base of the heart (for claim 3, the distal end is considered the end closest to the tubular body 10a).
For claim 4, Greenberg discloses the device of claim 1, wherein the first outflow port is arranged lateral to the longitudinal axis and at an oblique angle to the longitudinal axis, with a distal end of the first outflow port pointing in a direction toward the apex of the heart (fig. 9).
For claim 5, Greenberg discloses the device of claim 1, further comprising a material 82 configured to at least partially cover the tubular body (fig. 9).
For claim 6, Greenberg discloses the device of claim 5, wherein the material is arranged on the tubular body such that it prevents blood flow through at least side portions of the tubular body (graft material prevents blood flow, e.g., para. 55).
For claim 7, Greenberg discloses the device of claim 5, wherein arrangement of the material on the tubular body is configured to allow inflow of blood from the azygos/innominate and/or hepatic veins (fig. 9, graft is located above and below these locations and thus does not block blood flow).
For claim 10, Greenberg discloses the device of claim 1, wherein the first outflow port includes at least one of a first restriction 58 and a second restriction 80, each configured to prevent migration of a valve arranged therein.
For claim 11, Greenberg discloses the device of claim 1, wherein the first outflow port includes at least one restriction 58, configured as a bottleneck structure, the bottleneck structure being within the first outflow port, or, the first outflow port is configured with an hourglass shape such that the bottleneck structure is within the hourglass structure, the bottleneck structure configured to prevent migration of a valve arranged within the first outflow port (fig. 9).
For claim 12, Greenberg discloses the device of claim 1, wherein the first outflow port includes a first stopper position 80, arranged on a distal end of the first outflow port, the first stopper portion configured to prevent migration of a valve arranged within the first outflow port away from the tubular body (fig. 9).
For claim 13, Greenberg discloses the device of claim 1, wherein the first outflow port includes a first stopper portion 58, arranged on a proximal end of the first outflow port, the first stopper portion configured to prevent migration of a valve arranged within the first outflow port toward the tubular body (fig. 9).
For claim 14, Greenberg discloses the device of claim 1, wherein the first outflow port includes a first stopper position 80 arranged on a distal end of the first outflow port, the first stopper portion configured to prevent migration of a valve arranged within the first outflow port away from the tubular body, and a second stopper portion 58, arranged on a proximal end of the first outflow port, the second stopper portion configured to prevent migration of a valve arranged within the first outflow port toward the tubular body (fig. 9).
For claim 15, Greenberg discloses the device of claim 1, wherein the first outflow port includes a limiting structure 80 arranged on a distal end of the first outflow port, the limiting structure configured to prevent migration of a valve arranged within the first outflow port away from the tubular body.
For claim 16, Greenberg discloses the device of claim 1, wherein at least one of a proximal end and a distal end of the first outflow port includes a diameter less than a diameter of a central portion of the first outflow port, which are configured to prevent migration of a valve arranged within the first outflow port (fig. 9).
For claim 17, Greenberg discloses the device of claim 1, wherein the first outflow port includes a stent structure 66 configured as a spring and configured to provide an inward radial force on the first outflow port.
For claim 18, Greenberg discloses the device of claim 1, further comprising a skirt 82 comprised of sealing material (para. 55) and arranged at least one of in and around the tubular body.
For claim 19, Greenberg discloses the device of claim 18, wherein the skirt is configured to prevent a backflow of blood from the right atrium to the inferior vena cava (fig. 9).
For claim 33, Greenberg discloses the device of claim 1, wherein the tubular body includes a rigidity that varies at different portions thereof (fig. 9, stented and non-stented portions have different rigidity).
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.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg (Pub. No.: US 2006/0276813).
For claims 8 and 9, Greenberg does not specify the embodiment of figure 9 further comprising a lead port arranged on the side of the tubular body, however, in figure 10, Greenberg teaches the use of lead port 94 on the side of the tubular body. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the Greenberg figure 9 device with a lead port as taught by the figure 10-11 embodiments for the purpose of providing additional conduits for blood flow and/or pacemaker or lead port passage. This modification would have occurred using known methods and would have yielded predictable results.
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774